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The Journal of Implant & Advanced Clinical Dentistry VOLUME 5, NO. 7 JULY 2013 Stereolithographic Surgical Implant Guides Ridge Augmentation with rh-BMP2

Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

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Page 1: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry

Volume 5, No. 7 July 2013

Stereolithographic Surgical Implant Guides

Ridge Augmentation with rh-BMP2

Page 2: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

Built-in platform shiftingDual-function prosthetic connection

Bone-condensing property

Adjustable implant orientation for optimal final placement

High initial stability, even in compromised

bone situations

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A new direction for implants.

Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free 800 993 8100; Tech. services 888 725 7100; Fax 714 282 9023Nobel Biocare Canada, Inc. 9133 Leslie Street, Unit 100, Richmond Hill, ON L4B 4N1; Phone 905 762 3500; Toll free 800 939 9394; Fax 800 900 4243Disclaimer: Some products may not be regulatory cleared/released for sale in all markets. Please contact the local Nobel Biocare sales office for current product assortment and availability. Nobel Biocare, the Nobel Biocare logotype and all other trademarks are, if nothing else is stated or is evident from the context in a certain case, trademarks of Nobel Biocare.

NobelActive equally satisfies surgical and restorative clinical goals. NobelActive thread design progressively condenses bone with each turn during insertion, which is designed to enhance initial stability. The sharp apex and cutting blades allow surgical clinicians to adjust implant orientation for optimal positioning of the prosthetic

connection. Restorative clinicians benefit by a versatile and secure internal conical prosthetic connec-tion with built-in platform shifting upon which they can produce excellent esthetic results. Based on customer feedback and market demands for NobelActive, theproduct assortment has been expanded – dental professionals will

now enjoy even greater flexi bility in prosthetic and implant selection. Nobel Biocare is the world leader in innovative evidence-based dental solutions. For more information, con-tact a Nobel Biocare Representative at 800 322 5001 or visit our website.

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Page 3: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

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Oralife is a single donor grafting product processed in accordance with AATB standards as well as state and federal regulations (FDA and the states of Florida, California, Maryland and New York). Oralife allografts are processed by LifeLink Tissue Bank and distributed by Exactech Inc.1. Data on file at Exactech. 2. McAllister BS, Hagnignat K. Bone augmentation techniques. J Periodontal. 2007 Mar; 78(3):377-96. 3. Blum B, Moseley J, Miller L, Richelsoph K, Haggard W. Measurement of bone morphogenetic proteins and

other growth factors in demineralized bone matrix. Orthopedics. 2004 Jan;27(1 Suppl):s161-5.

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Page 4: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

IntroducIng

Less pain for your patients.1

Less chair side time for you.1

Mucograft® is a pure and highly biocompatible porcine collagen matrix. The spongious nature of Mucograft® favors early vascularization and integration of the soft tissues. It degrades naturally, without device related inflammation for optimal soft tissue regeneration. Mucograft® collagen matrix provides many clinical benefits:

For your patients...

Patients treated with Mucograft® require 5x less Ibuprofen than

those treated with a connective tissue graft1

Patients treated with Mucograft® are equally satisfied with esthetic outcomes when compared to connective tissue grafts2

For you...

Surgical procedures with Mucograft® are 16 minutes shorter in duration on average when compared to those involving connective tissue grafts1

Mucograft® is an effective alternative to autologous grafts3, is ready to use and does not require several minutes of washing prior to surgery

For full prescribing information, please visit us online at www.osteohealth.com or call 1-800-874-2334

References: 1Sanz M, et. al., J Clin Periodontol 2009; 36: 868-876. 2McGuire MK, Scheyer ET, J Periodontol 2010; 81: 1108-1117. 3Herford AS., et. al., J Oral Maxillofac Surg 2010; 68: 1463-1470. Mucograft® is a registered trademark of Ed. Geistlich Söhne Ag Fur Chemische Industrie and are marketed under license by Osteohealth, a Division of Luitpold Pharmaceuticals, Inc. ©2010 Luitpold Pharmaceuticals, Inc. OHD240 Iss. 10/2010

Mucograft® is indicated for guided tissue regeneration procedures in periodontal and recession defects, alveolar ridge reconstruction for prosthetic treatment, localized ridge augmentation for later implantation and covering of implants placed in immediate or delayed extraction sockets. For full prescribing information, visit www.osteohealth.com

Ask about our limited time, introductory special!

Page 5: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry • 3

The Journal of Implant & Advanced Clinical DentistryVolume 5, No. 7 • July 2013

Table of Contents

IntroducIng

Less pain for your patients.1

Less chair side time for you.1

Mucograft® is a pure and highly biocompatible porcine collagen matrix. The spongious nature of Mucograft® favors early vascularization and integration of the soft tissues. It degrades naturally, without device related inflammation for optimal soft tissue regeneration. Mucograft® collagen matrix provides many clinical benefits:

For your patients...

Patients treated with Mucograft® require 5x less Ibuprofen than

those treated with a connective tissue graft1

Patients treated with Mucograft® are equally satisfied with esthetic outcomes when compared to connective tissue grafts2

For you...

Surgical procedures with Mucograft® are 16 minutes shorter in duration on average when compared to those involving connective tissue grafts1

Mucograft® is an effective alternative to autologous grafts3, is ready to use and does not require several minutes of washing prior to surgery

For full prescribing information, please visit us online at www.osteohealth.com or call 1-800-874-2334

References: 1Sanz M, et. al., J Clin Periodontol 2009; 36: 868-876. 2McGuire MK, Scheyer ET, J Periodontol 2010; 81: 1108-1117. 3Herford AS., et. al., J Oral Maxillofac Surg 2010; 68: 1463-1470. Mucograft® is a registered trademark of Ed. Geistlich Söhne Ag Fur Chemische Industrie and are marketed under license by Osteohealth, a Division of Luitpold Pharmaceuticals, Inc. ©2010 Luitpold Pharmaceuticals, Inc. OHD240 Iss. 10/2010

Mucograft® is indicated for guided tissue regeneration procedures in periodontal and recession defects, alveolar ridge reconstruction for prosthetic treatment, localized ridge augmentation for later implantation and covering of implants placed in immediate or delayed extraction sockets. For full prescribing information, visit www.osteohealth.com

Ask about our limited time, introductory special!

11 Alveolar Ridge Augmentation Using Recombinant Human Bone Morphogenic Protein (rhBMP-2): A Literature Review and Histologic Case Report Bassam M. Kinaia, Michael Ramos, Sami Chogle, Leyvee Cabanilla Jacobs, Maanas S. Shah

25 Accuracy of Implant Placement Using Modified Mucosa-Supported Steriolithographic Surgical Guide Dr. Mostafa Omran Hussein, Dr. Amr El Karargy

Page 6: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free
Page 7: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry • 5

The Journal of Implant & Advanced Clinical DentistryVolume 5, No. 7 • July 2013

Table of Contents

37 Success of Early Loading Dental Implants on Deficient Anterior Maxillae Augmented with Block Allografts Capt (Dr) Varun Choudhary, Col (Dr) S K Rath2

49 Clinical Assessment of Fluorosis and the Effects of Mitigation Measures in Endemic Areas of Mehsana, Gujarat, India Ashish Sharma, P.S. Ganguly, Anjali Kothari

Page 8: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

Blue Sky Bio, LLC is a FDA registered U.S. manufacturer of quality implants and not affi liated with Nobel Biocare, Straumann AG or Zimmer Dental. SynOcta® is a registered trademark of Straumann AG. NobelReplace® is a registered trademark of Nobel Biocare. Tapered Screw Vent® is a registered trademark of Zimmer Dental.

*activFluor® surface has a modifi ed topography for bone apposition on the implant surface without additional chemical activity.

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Page 9: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry • 7

The Journal of Implant & Advanced Clinical DentistryVolume 5, No. 7 • July 2013

PublisherLC Publications

DesignJimmydog Design Group www.jimmydog.com

Production ManagerStephanie Belcher 336-201-7475 • [email protected]

Copy EditorJIACD staff

Digital ConversionNxtBook Media

Internet ManagementInfoSwell Media

Subscription Information: Annual rates as follows: Non-qualified individual: $99(USD) Institutional: $99(USD). For more information regarding subscriptions, contact [email protected] or 1-888-923-0002.

Advertising Policy: All advertisements appearing in the Journal of Implant and Advanced Clinical Dentistry (JIACD) must be approved by the editorial staff which has the right to reject or request changes to submitted advertisements. The publication of an advertisement in JIACD does not constitute an endorsement by the publisher. Additionally, the publisher does not guarantee or warrant any claims made by JIACD advertisers.

For advertising information, please contact:[email protected] or 1-888-923-0002

Manuscript Submission: JIACD publishing guidelines can be found at http://www.jiacd.com/author-guidelines or by calling 1-888-923-0002.

Copyright © 2013 by LC Publications. All rights reserved under United States and International Copyright Conventions. No part of this journal may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying or any other information retrieval system, without prior written permission from the publisher.

Disclaimer: Reading an article in JIACD does not qualify the reader to incorporate new techniques or procedures discussed in JIACD into their scope of practice. JIACD readers should exercise judgment according to their educational training, clinical experience, and professional expertise when attempting new procedures. JIACD, its staff, and parent company LC Publications (hereinafter referred to as JIACD-SOM) assume no responsibility or liability for the actions of its readers.

Opinions expressed in JIACD articles and communications are those of the authors and not necessarily those of JIACD-SOM. JIACD-SOM disclaims any responsibility or liability for such material and does not guarantee, warrant, nor endorse any product, procedure, or technique discussed in JIACD, its affiliated websites, or affiliated communications. Additionally, JIACD-SOM does not guarantee any claims made by manufact-urers of products advertised in JIACD, its affiliated websites, or affiliated communications.

Conflicts of Interest: Authors submitting articles to JIACD must declare, in writing, any potential conflicts of interest, monetary or otherwise, that may exist with the article. Failure to submit a conflict of interest declaration will result in suspension of manuscript peer review.

Erratum: Please notify JIACD of article discrepancies or errors by contacting [email protected]

JIACD (ISSN 1947-5284) is published on a monthly basis by LC Publications, Las Vegas, Nevada, USA.

Page 10: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

For more information, contact BioHorizonsCustomer Care: 1.888.246.8338 or shop online at www.biohorizons.com

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The Tapered Plus implant system offers all the great benefits of BioHorizons highly successful Tapered Internal system PLUS it features a Laser-Lok treated beveled-collar for bone and soft tissue attachment and platform switching designed for increased soft tissue volume.

Laser-Lok® zoneCreates a connective tissue seal and maintains crestal bone

platform switchingDesigned to increase soft tissue volume around the implant connection

optimized threadformButtress thread for primary stability and maximum bone compression

prosthetic indexingConical connection with internal hex; color-coded for easy identification

Page 11: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry • 9

Tara Aghaloo, DDS, MDFaizan Alawi, DDSMichael Apa, DDSAlan M. Atlas, DMDCharles Babbush, DMD, MSThomas Balshi, DDSBarry Bartee, DDS, MDLorin Berland, DDSPeter Bertrand, DDSMichael Block, DMDChris Bonacci, DDS, MDHugo Bonilla, DDS, MSGary F. Bouloux, MD, DDSRonald Brown, DDS, MSBobby Butler, DDSNicholas Caplanis, DMD, MSDaniele Cardaropoli, DDSGiuseppe Cardaropoli DDS, PhDJohn Cavallaro, DDSJennifer Cha, DMD, MSLeon Chen, DMD, MSStepehn Chu, DMD, MSD David Clark, DDSCharles Cobb, DDS, PhDSpyridon Condos, DDSSally Cram, DDSTomell DeBose, DDSMassimo Del Fabbro, PhDDouglas Deporter, DDS, PhDAlex Ehrlich, DDS, MSNicolas Elian, DDSPaul Fugazzotto, DDSDavid Garber, DMDArun K. Garg, DMDRonald Goldstein, DDSDavid Guichet, DDSKenneth Hamlett, DDSIstvan Hargitai, DDS, MS

Michael Herndon, DDSRobert Horowitz, DDSMichael Huber, DDSRichard Hughes, DDSMiguel Angel Iglesia, DDSMian Iqbal, DMD, MSJames Jacobs, DMDZiad N. Jalbout, DDSJohn Johnson, DDS, MSSascha Jovanovic, DDS, MSJohn Kois, DMD, MSDJack T Krauser, DMDGregori Kurtzman, DDSBurton Langer, DMDAldo Leopardi, DDS, MSEdward Lowe, DMDMiles Madison, DDSLanka Mahesh, BDSCarlo Maiorana, MD, DDSJay Malmquist, DMDLouis Mandel, DDSMichael Martin, DDS, PhDZiv Mazor, DMDDale Miles, DDS, MSRobert Miller, DDSJohn Minichetti, DMDUwe Mohr, MDTDwight Moss, DMD, MSPeter K. Moy, DMDMel Mupparapu, DMDRoss Nash, DDSGregory Naylor, DDSMarcel Noujeim, DDS, MSSammy Noumbissi, DDS, MSCharles Orth, DDSAdriano Piattelli, MD, DDSMichael Pikos, DDSGeorge Priest, DMDGiulio Rasperini, DDS

Michele Ravenel, DMD, MSTerry Rees, DDSLaurence Rifkin, DDSGeorgios E. Romanos, DDS, PhDPaul Rosen, DMD, MSJoel Rosenlicht, DMDLarry Rosenthal, DDSSteven Roser, DMD, MDSalvatore Ruggiero, DMD, MDHenry Salama, DMDMaurice Salama, DMDAnthony Sclar, DMDFrank Setzer, DDSMaurizio Silvestri, DDS, MDDennis Smiler, DDS, MScDDong-Seok Sohn, DDS, PhDMuna Soltan, DDSMichael Sonick, DMDAhmad Soolari, DMDNeil L. Starr, DDSEric Stoopler, DMDScott Synnott, DMDHaim Tal, DMD, PhDGregory Tarantola, DDSDennis Tarnow, DDSGeza Terezhalmy, DDS, MATiziano Testori, MD, DDSMichael Tischler, DDSTolga Tozum, DDS, PhDLeonardo Trombelli, DDS, PhDIlser Turkyilmaz, DDS, PhDDean Vafiadis, DDSEmil Verban, DDSHom-Lay Wang, DDS, PhDBenjamin O. Watkins, III, DDSAlan Winter, DDSGlenn Wolfinger, DDSRichard K. Yoon, DDS

Editorial Advisory Board

Founder, Co-Editor in ChiefDan Holtzclaw, DDS, MS

Founder, Co-Editor in ChiefNicholas Toscano, DDS, MS

The Journal of Implant & Advanced Clinical Dentistry

For more information, contact BioHorizonsCustomer Care: 1.888.246.8338 or shop online at www.biohorizons.com

SPMP12245 REV A SEP 2012

make the switch

The Tapered Plus implant system offers all the great benefits of BioHorizons highly successful Tapered Internal system PLUS it features a Laser-Lok treated beveled-collar for bone and soft tissue attachment and platform switching designed for increased soft tissue volume.

Laser-Lok® zoneCreates a connective tissue seal and maintains crestal bone

platform switchingDesigned to increase soft tissue volume around the implant connection

optimized threadformButtress thread for primary stability and maximum bone compression

prosthetic indexingConical connection with internal hex; color-coded for easy identification

Page 12: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

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Page 13: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

Wilcko et al

Background: Alveolar ridge deficiency is a common occurrence after tooth extraction creat-ing a challenge to clinicians attempting to obtain predictable results for future implant placement. The use of bone grafts and growth and differ-entiating factors such as recombinant human bone morphogenic proteins (rhBMP-2) are well documented in alveolar ridge augmentation. The current clinical, radiographic and histo-logic case report presents the use of rhBMP-2 in alveolar ridge and sinus lift augmentation.

Methods: A 76-year-old male patient, in good general health, nonsmoker, presented with partial edentulous maxilla and retained maxil-lary canines. Maxillary anterior alveolar ridge and bilateral sinus augmentations were com-pleted using rhBMP-2 solution uniformly dis-pensed over an absorbable collagen sponge (ACS) mixed with a xenograft bone material.

A Titanium Mesh was used to aid in space maintenance for lateral ridge augmentation. CBCT and histologic core biopsies were per-formed to evaluate the new bone formation.

Results: After 7 months of healing, the CBCT revealed an increase in bone height from 7.27 ± 1.69 mm to 13.43 ± 2.43 mm for the max-illary sinuses. With regard to the maxillary ante-rior region, there was an increase in ridge width with horizontal bone gain from 5.76 ± 2.10 mm to 9.68 ± 0.39 mm. The histologic report indicated new vital bone induction by rhBMP-2 showing presence of woven and lamellar bone. Four dental implants were placed and successfully restored.

Conclusions: The use of rhBMP-2 in maxil-lary sinus and lateral ridge augmentation pro-cedures showed positive clinical results as confirmed by radiographic and histologic analysis.

Alveolar Ridge Augmentation Using Recombinant Human Bone Morphogenic Protein (rhBMP-2):

A Literature Review and Histologic Case Report

Bassam M. Kinaia, DDS, MS1 • Michael Ramos, DDS, MS2 Sami Chogle, DMD, MSD3 • Leyvee Cabanilla Jacobs DDS, MS4

Maanas S. Shah, BDS, MSD5

1. Associate Professor, Department of Periodontology, University of Detroit – Mercy, School of Dentistry, Detroit, MI, USA. Private Practice Limited to Periodontics and Dental Implants. Sterling Heights, MI, USA.

2. Private Practice Limited to Periodontics and Dental Implants. Rochester Hills, MI, USA.

3. Chair and Director, Postgraduate Endodontic Program, Endodontic Department, Goldman School of Dental Medicine, Boston, MA, USA.

4. Associate Professor, Department of Periodontology, University of Detroit – Mercy, School of Dentistry, Detroit, MI, USA.

5. Private Practice Limited to Periodontics and Dental Implants. Dubai School of Dental Medicine, DHCC, Dubai, UAE.

Abstract

KEY WORDS: Bone morphogenic protein, growth factors, guided bone regeneration, maxillary sinus, bone grafts, dental implant

The Journal of Implant & Advanced Clinical Dentistry • 11

Page 14: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

12 • Vol. 5, No. 7 • July 2013

INTRODUCTIONDental implants are a universal treatment option for patients. However, clinicians are often faced with limited bone presence, especially when teeth have been lost for a long period of time. Alveo-lar bone deficiency is a natural consequence of tooth extraction resulting in resorption of the edentulous ridge.1 An average of 40% to 60% of the original alveolar bone height and width is lost after tooth extraction, with the greatest loss occurring within the first two years.2 Many clas-sifications exist to describe the morphology and to quantify the severity of alveolar ridge resorp-tion.3-6 Wang et al. quantified the alveolar ridge deficiency and expanded on Siebert’s classifica-tion by recommending treatment options based on the severity of the deficiency and defined it as small ( < 3mm), medium (4-6mm), and large ( > 7mm).6 In addition, the span of the edentulous ridge also plays an important role in treatment planning ridge reconstruction and consequently the enhancement of ideal implant placement. Thus, alveolar ridge and maxillary sinus augmen-tation procedures have been attempted with suc-cessful results with the goal of placing dental implants in a proper esthetic and functional posi-tion.7 Many techniques and materials have been used with bone grafts, guided bone regeneration and growth factors being the most relevant.8,9

LITERATURE REVIEWBone Grafts and Guided Bone regenerationBone grafts have long been used for treat-ment and correction of alveolar ridge deficien-cies. The rationale behind using bone grafts is that they possess osteogenic (autograft), osteoinductive (autograft/allograft), or osteo-conductive (xenograft/alloplast) properties.10

In periodontal regeneration, Melcher in 1976 reported barrier mediated selective cell repopu-lation that gave rise to the concept of epithelial exclusion to restore lost periodontal tissue and obtain new attachment.11 This same concept is applied to regenerate lost alveolar bone known as Guided bone regeneration (GBR). GBR is used to regenerate bone in preparation for implant site development as in ridge and sinus augmentation or around exposed threads of dental implants.

Growth and Differentiating Factors In addition to bone graft, growth and differ-entiating factors that can aid in periodontal regeneration and bone induction, growth and differentiation factors play an important role in regulating wound-healing events such as che-motaxis, cell adhesion, proliferation, and differen-tiation.12 These factors include platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), transforming growth fac-tors (TGF-α and -β), acidic and basic fibroblast growth factors (a- and b-FGF), epidermal growth factor (EGF), insulin-like growth factors (IGF-I and -II), cementum-derived growth factor (CGF), parathyroid hormone-related protein (PTHrP), and bone morphogenetic proteins (BMPs).13

The most investigated growth factors for osteoinductive activity include PDGF, PTH, and BMPs.14-21 BMPs are differentiating factors belonging to the transforming growth factor-β [TGF-β] superfamily. They play a major role in bone formation and maintenance through differ-entiation, cell migration, proliferation and apop-tosis. The most profound characteristic effect observed for BMPs are their ability to differen-tiate mesenchymal progenitor cells into chon-droblasts and osteoblasts.22 There are over 20

Kinaia et al

Page 15: Stereolithographic Surgical Implant Guides · A new direction for implants. Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Linda, CA 92887; Phone 714 282 4800; Toll free

The Journal of Implant & Advanced Clinical Dentistry • 13

BMPs present with BMP-2 (Osteogenic Pro-tein-2 [OP-2]), BMP-3 (Osteogenin), and BMP-7 (Osteogenic Protein-1 [OP-1]), BMP-12 (also known as Growth Differentiation Factor-7 [GDF-7]) and BMP-14 (also known as Growth Dif-ferentiation Factor-5 [GDF-5]) being the most prevalent ones in regenerative therapy.23 In early 2007, INFUSE® bone graft (Medtronic Sofamor Danek, Memphis, TN) was approved by the United States Food and Drug Administration (FDA) as an alternative to bone grafts for sinus and localized alveolar ridge augmentations.24 BMP-2 and -3 have shown good potential to correct intrabony and furcation bone loss. How-ever, BMP-2 has been associated with ankylosis histologically.25,26 Therefore, they are generally reserved for use around implants or for guided-bone regeneration. Although these growth and differentiating factors have been used with good clinical results, rhBMP-2 remains to be the most prevalent one in alveolar ridge augmentation.

Clinical Studies using rhBMP-2Various randomized clinical trials (RCT) and case reports have been published discussing the quality and quantity of bone regenerated using rhBMP-2 in maxillary sinus augmentation.27-30

The first multicenter RCT was designed to evalu-ate the safety and efficacy of rhBMP-2 in maxil-lary sinus augmentation. The mean increase in alveolar ridge height ranged from 9.5 mm to 10.2 mm.27 These results were comparable to the newly induced bone using autogenous or com-bination of autogenous/allogenous bone.29 Later studies showed that extensive sinus membrane elevation is required with rhBMP-2 due to con-siderable graft shrinkage and low initial graft den-sity.30 To overcome these drawbacks, Tarnow et al.

proposed that graft shrinkage might be prevented by the addition of xenograft and/or allograft within the Acellular Collagen Sponge (ACS).30

With regard to lateral ridge augmentation, Howell et al conducted the first safety and tech-nical feasibility human study for use of rhBMP-2. The 16-week study, demonstrated no increase in alveolar ridge width or height with rhBMP-2 alone.31 Thereafter, Cochran et al. followed up the functional stability of dental implants placed in the augmented sites in the previous study for three years. The amount of new bone growth that was induced in these sites was minimal to even less than baseline.32 These studies failed to describe adequate conclusions due to the small sample size, lack of a control group and negli-gible bone growth. While comparing these find-ings with those of horizontal ridge augmentation obtained with conventional particulate bone sub-stitutes and membranes, it is important to men-tion that a superior result of gain in ridge width of 3.6 mm could be recorded for conventional bone substitutes.8 However, preclinical investiga-tions in dogs have revealed that the compromised results with rhBMP-2/ACS alone were due to the failure of the ACS to adequately maintain support in supraalveolar wound space.33 A prospective RCT addressed the insufficient mechanical prop-erties of ACS and proposed a combination of an osteoinductive protein (rhBMP-2) with an osteo-conductive material to overcome some of the dif-ficulties encountered.34 The study compared the quantity of bone that was induced using rhBMP-2 plus xenograft (test) versus xenograft alone (con-trol) and showed no statistical difference in the amount of bone augmentation observed between the two groups. However, the study demonstrated the beneficial effects of higher bone maturation

Kinaia et al

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and increased graft to bone contact when com-bining rhBMP-2 with a xenogenic bone mate-rial.34 The histomorphometric analysis for this study revealed a higher percentage of newly formed bone at the rhBMP-2 test sites 37% versus 30% of newly formed bone at the con-trol sites. In addition, the fraction of mineralized bone identified as lamellar bone amounted to 76% (test) compared to 56% (control) indicat-ing that rhBMP-2 accelerated the mineralization and maturation process. Further, the mean ver-tical defect fill (91%) at the control defects with xenograft alone corresponded well with the previ-ous clinical studies (mean vertical defect fill 86%).

Although not significant, the mean vertical defect fill at the rhBMP-2 treated sites was slightly bet-ter (96%) than control sites. The authors under-scored the necessity to maintain space by adding xenogenic bone material to the osteoinductive rhBMP-2 for enhanced results.34 Implant survival rates in test sites over three to five years were 100% which is in agreement with other system-atic review that reported high survival of implants (median 100%) placed in regenerated bone.8

On the histologic level, previous studies reported definite bone induction using rhBMP-2 in maxillary sinus and alveolar ridge augmen-tation procedures.27,29,31,35 Qualitative analy-sis of bone formation showed presence of moderate to large amounts of trabecular bone in the newly induced region with variations of woven bone (small to moderate) and/or, remod-eling of woven bone to lamellar bone and/or presence of moderate to large amounts of lamellar bone alone. At the cellular level, small

Figure 1: Pre-op facial view of anterior maxillary region.

Figure 2: Pre-op occlusal clinical view and cone beam computed tomography scan of the maxilla.

Figure 3: rhBMP-2/ACS mixed with xenograft bone material.

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to moderate amounts of osteoblasts were pres-ent along with intermittent, smaller amounts of osteoclasts. Further, there was no evidence of remaining residual collagen sponge material in any of the rhBMP-2/ACS treated specimens with very few inflammatory cell infiltration.27,29,31,35

CASE REPORTThe current case report evaluates the use of 1.5 mg/ml rhBMP-2 with an absorbable collagen sponge (ACS) mixed with a bone replacement graft for lateral ridge augmen-

tation and bilateral sinus lift augmentation procedures. A specific technique for space maintenance to achieve anterior ridge aug-mentation is described. The clinical, radio-graphic and histologic results are presented.

Figure 4: Occlusal view of Titanium Mesh secured with screws.

Figure 6: Post-op view of primary closure.

Figure 5: Placement of rhBMP-2/ACS and Xenograft bone material.

Figure 7: rhBMP-2/ACS mixed with xenograft bone material.

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Initial Presentation A healthy 76-year-old male patient presented with a partially edentulous maxilla and retained periodontally involved left and right maxillary canines (Figure 1). The clinical and radiographic examination revealed a class III ridge deficiency3 for the anterior maxilla with bilateral maxillary sinus pneumatization (Figure 2). The treatment plan included anterior lateral ridge augmenta-tion with bilateral maxillary sinus augmentation for dental implant supported maxillary fixed pros-

thesis. An experienced periodontist (MR) per-formed the surgical procedure in its entirety.

Surgical Procedure (Anterior Ridge and Bilateral Maxillary Sinus Augmentations)The patient received Amoxicillin 500 mg (Teva Pharmaceuticals, Sellersville, PA, USA) starting 24 hours before the procedure and for seven days after. Presurgically the patient rinsed with a 0.12% chlorhexidine (Hi-Tech Pharmacal Co., Inc. Ami-tyville, NY, USA) solution for a minute and local

Figure 8: Facial view of rhBMP-2ACS and xenograft placed in the maxillary sinus.

Figure 10: Re-entry facial view showing bone formation within the titanium mesh.

Figure 9: Facial view of alveolar ridge healing at 7 months.

Figure 11: Clinical view showing bone formation within the Titanium Mesh.

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anesthesia administered using 2% lidocaine with 1:100,000 epinephrine (Empi, Inc., St. Paul, MN, USA). Periotomes were used to severe periodon-tal ligaments to facilitate extractions of #6, 11 with minimal trauma. The sockets were thoroughly debrided and facial bone loss was present affect-ing the coronal 1/2 of the sockets. A midcrestal incision was made with mucoperiosteal flap eleva-tion to expose the ridge crest and facial cortex in the maxillary anterior region. The recipient bed was prepared by decorticating the ridge using a

round bur to expose the cancellous bone. Using aseptic technique, 8.0 mg of lyophilized rhBMP-2 (INFUSE® Bone Graft, Medtronic Sofamor Danek, Memphis, TN, USA) was reconstituted with 1.8 ml sterile water, gently rotated and withdrawn with sterile 5cc syringe. Two sterile (1 x 2 inches) ACS were prepared and the 2.0 ml aliquot of the 1.5 mg/ml rhBMP-2 solution was withdrawn and uniformly dispensed over them and allowed to soak for 20 minutes (binding period of the growth factor to the collagen barrier). The ACS were cut

Figure 12: Core biopsy obtained using a 2.0 mm trephine drill.

Figure 14: Surgical guide for implant placement.

Figure 13: A 2x6 mm core biopsy obtained for histologic analysis.

Figure 15: Four dental implants placed.

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Figure 16: Radiographs of abutments connected to implants.

Figure 17: Radiographs of final maxillary fixed partial denture.

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Figure 18: Post-op occlusal clinical view and cone beam computed tomography scan of the maxilla.

into 3 x 3 mm pieces and mixed with small quantity of xenograft bone material (BioOss, Geistlich Bio-materials, Inc., Wolhusen, Switzerland) (Figure 3).

For the purpose of space maintenance, Tita-nium Mesh device (TiMesh® Medtronic Goleta, CA, USA) was used, contoured and stabilized with bone screws to increase the horizontal width of the alveolar ridge (Figure 4). The combina-tion preparation of rhBMP-2/ACS and xenograft was placed in the defect area and the sockets and gently compressed to fill the space up to the TiMesh surface (Figure 5). Primary closure was achieved by coronally advancing the flap and secured using 4-O vicryl (Polyglactin 910, Ethi-con Inc., Johnson & Johnson Company, Somer-ville, NJ, USA) interrupted sutures (Figure 6). The patient was monitored periodically and the grafted sites were allowed to heal for 6 months.

The maxillary sinus augmentation was per-formed within 2 months after anterior ridge aug-mentation. Presurgical protocol was similar to ridge augmentation. An incision was made along the ridge crest with mucoperiosteal flap eleva-

tion to expose the maxillary posterior regions. Lateral window was outlined and schneiderian membrane elevated using special sinus curettes. Similarly to the anterior ridge augmentation, 1.5 mg/ml rhBMP-2/ACS were prepared, mixed with xenograft (Figure 7), and placed into the sinuses bilaterally (Figure 8). Primary closure was obtained using 4-0 interrupted vicryl sutures and the areas were allowed to heal for 7 months.

Re-Entry and Implant PlacementRe-entry was performed after 9 months of heal-ing (Figure 9). Under local anesthesia, an inci-sion was made with a mucoperiosteal flap elevation exposing the crest of the ridge and the facial cortex in the maxillary anterior region (Figure 10). The Ti Mesh was exposed and the screws removed. Interestingly, the Ti Mesh was intimately intertwined with the augmented bone and required removal as the bone grew into the indentations of the Ti Mesh (Figure 11).

Four 6 mm length core sample biopsies were obtained using 2.0 mm trephine drills from sites #6, 7, 10, 11 and labeled and sent to the lab for histological analysis (Figures 12, 13). Using the surgical guide, osteotomies were contin-ued according to the implant company proto-col and four implants (Osseotite®, Biomet 3i Inc., Palm Beach Gardens, FL, USA) sizes 4/3 x 10 mm for #6; 4/3 x 11.5 mm for #7; 4/3 x 10 mm for #10; and 4/3 x11.5 mm for #11 were placed with excellent primary stability (40 NcM) (Figures 14, 15). Primary closure was obtained and the implants were allowed to heal for 6 months before loading. Upon second stage sur-gery, the abutments were secured and verified using periapical radiographs and later restored

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CBCT Pre CBCT Post

Tooth No. Height Width Height Width

#3 5.03 11.40 13.2 13.50

#4 8.54 8.70 10.15 7.62

#13 8.60 7.21 14.59 11.29

#14 6.91 11.44 15.79 14.34

Mean ± SD 7.27 ± 1.69 9.69 ± 2.09 13.43 ± 2.43 11.69 ± 3.00 (in mm)

Table 1: Difference in the Amount of Bone Regenerated Before and After Maxillary Sinus Augmentation

CBCT Pre CBCT Post

Tooth No. Height Width Height Width

#6 13.74 9.53 15.32 9.83

#7 11.95 4.33 13.23 9.07

#8 11.82 4.46 17.52 9.40

#9 10.41 4.58 10.13 9.97

#10 12.94 4.67 14.85 10.13

#11 13.65 6.98 13.74 9.66

Mean ± SD 12.42 ± 1.28 5.76 ± 2.10 14.13 ± 2.47 9.68 ± 0.39 (in mm)

Table 2: Difference in the Amount of Bone Regenerated Before and After Lateral Ridge Augmentation in the Maxillary Anterior Region

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with maxillary fixed partial denture (Figures 16, 17).

RESULTSRadiographic Analysis Cone beam computed tomography (CBCT) scans were taken at initial presentation (Figure 2) and 6 months after ridge aug-mentation (Figure 18). A radiographic com-parison of the pre- and post- augmentation

procedures, revealed adequate bone for-mation and gain in horizontal and verti-cal ridge width. For the maxillary sinuses, there was an increase in bone height from 7.27 + 1.69 mm to 13.43 + 2.43 mm. A similar finding for ridge width occurred with increase in horizontal bone gain from 9.69 + 2.09 mm to 11.69 + 3.00 mm (Table 1). With regard to the maxillary anterior region, there was an increase in bone height from 12.42 + 1.28 mm to 14.13 + 2.47 mm. There was a significant increase in ridge width with horizontal bone gain from 5.76 + 2.10 mm to 9.68 + 0.39 mm (Table 2).

Histological Analysis A histological examination of the bone core biopsy specimens was conducted indicating new vital bone induction by rhBMP-2 (Figure 19). The post-surgical CBCT scan shows a demarcation line present (Figure 20). The line correlates with the histologic slides separating the native bone from the newly induced bone (Figure 21). The

Figure 20: Post Surgical CBCT showing demarcation line for tooth site #11.

Figure 19: Site #11 (20X magnification) showing trabecular bone presence.

Figure 21: Site #11 (40X magnification) showing demarcation line separating newly induced bone from native bone.

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qualitative analysis of bone formation showed presence of moderate to large amounts of tra-becular bone in the newly induced region contain-ing variable amounts of woven and lamellar bone.

DISCUSSIONAlveolar ridge and maxillary sinus augmentation procedures are well documented as success-ful procedures with predictable results.7,8 Many techniques and materials are used today with bone grafts being the predominant material uti-lized. The osteoinductive characteristics of the materials used plays a significant role in bone regeneration and hence growth factors are more often used today in addition or as an alternative to bone grafts.8,9 To date, the role of growth fac-tors such as bone morphogenic proteins remains to be experimental with more animal than human studies to support its clinical relevancy. Therefore, the aim of the current review and case report was to evaluate the quantity and quality of new bone regenerated using rhBMP-2 for alveolar ridge and maxillary sinus augmentation procedures.

The review of the literature reported a favor-able gain in alveolar bone height with the use of rhBMP-2 in maxillary sinus lift procedures.14 Since there is tendency for graft shrinkage with use of rhBMP-2/ACS alone, studies reported beneficial results with incorporation of a mineral-ized bone replacement graft into the infuse bone graft.30 They reported a mean height increase of 14.7 ± 2.76 mm in sinus lift procedures using rhBMP-2 with a bone substitute material (xeno-graft or allograft).30 In the current case report, a xenograft material was added to the rhBMP-2 to compensate for the possible shrinkage of the material. The results of the bilateral sinus lift are comparable to other studies with increase in

bone height from 7.27 + 1.69 mm to 13.43 + 2.43 mm and increase in horizontal bone gain from 9.69 + 2.09 mm to 11.69 + 3.00 mm.

Contrary to the bone height gain with sinus lift augmentation, the literature reported a loss in alveolar bone height (although slight) using rhBMP-2 alone (-0.08 + 2.5 mm) in lat-eral ridge augmentation procedures.32 With regard to bone width using rhBMP-2, only two studies reported the amount of horizon-tal bone augmentation. The bone gain was minimal ranging from 0.23 mm to 0.4 mm.31,32

Jung et al. showed that the beneficial effects of combining rhBMP-2 with a xenogenic bone material are a higher degree of bone matura-tion and an increased graft to bone contact where the bone substitute acted as a scaf-fold for space maintenance.34 In the current case report, an increase in bone height from 12.42 + 1.28 mm to 14.13 + 2.47 mm was obtained with a significant increase in ridge width from 5.76 + 2.10 to 9.68 + 0.39 mm. These results were superior to those discussed above. It is the authors’ opin-ion that this increase is attributed to the added use of TiMesh and xenograft for space maintenance. Such significant gain in alveolar ridge augmentation has recently been reported in human studies.35,36

CONCLUSIONAlthough the advent of osteoinductive growth factors such as rhBMP-2 along with traditional bone graft materials has opened new horizons in the field of guided bone regeneration therapy, the clinical documentation of use of rhBMP-2 based on the current literature review is sparse. There is a distinct lack of total number of inves-

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tigations as well as randomized controlled trials that compare and contrast the use of rhBMP-2 in augmentation of localized ridge deficiencies. Nonetheless, the use of rhBMP-2 mixed with bone graft substitute in maxillary sinus and lat-eral ridge augmentation procedures along with titanium mesh for space maintenance shows positive initial clinical results. Further research may prove growth factors to be an additional armamentarium in bone augmentation. ●

Correspondence:

Bassam M. Kinaia, DDS, MS

2452 Westmont Cr.

Sterling Heights, MI 48310, USA

1 (586) 275-5570

[email protected]

[email protected]

DisclosureThe authors report no conflicts of interest with anything mentioned in this article.

References 1. Mecall RA, Rosenfeld AL. Influence of residual

ridge resorption patterns on implant fixture place-ment and tooth position. Int J Periodontics Resto-rative Dent 1991; (11)1: 8-23.

2. Grunder U, Polizzi G, Goene R, Hatano N, Henry P, Jackson WJ, et al. A 3-year prospective mul-ticenter follow-up report on the immediate and delayed-immediate placement of implants. Int J Oral Maxillofac Implants 1999; (14)2: 210-6.

3. Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Com-pend Contin Educ Dent 1983; (4)5: 437-53.

4. Allen EP, Gainza CS, Farthing GG, Newbold DA. Improved technique for localized ridge augmenta-tion. A report of 21 cases. J Periodontol 1985; (56)4: 195-9.

5. Misch CE, Judy KW. Classification of partially edentulous arches for implant dentistry. Int J Oral Implantol 1987; (4)2: 7-13.

6. Wang HL, Al-Shammari K. HVC ridge deficiency classification: a therapeutically oriented classifica-tion. Int J Periodontics Restorative Dent 2002; (22)4: 335-43.

7. McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol 2007; (78)3: 377-96.

8. Jensen SS, Terheyden H. Bone augmentation procedures in localized defects in the alveolar ridge: clinical results with different bone grafts and bone-substitute materials. Int J Oral Maxillofac Implants 2009; (24)Suppl: 218-36.

9. Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants 2009; (24)Suppl: 237-59.

10. Lindhe J., Karring T., Lang NP. Clinical Periodon-tology and Implant Dentistry, Oxford, UK: Black-well Munksgaard; 2003: 667-8.

11. Melcher AH. On the repair potential of periodon-tal tissues. J Periodontol 1976; (47)5: 256-60.

12. Bartold PM., Narayanan AS. Biology of the Peri-odontal Connective Tissues. Carol Stream, Il: Quintessence Publishing Co. Inc; 1998: 245-6.

13. AAP Position Paper. The potential role of growth and differentiation factors in periodontal regen-eration. J Periodontol 1996; (67)5: 545-53.

14. Jung RE, Thoma DS, Hammerle CH. Assess-ment of the potential of growth factors for local-ized alveolar ridge augmentation: a systematic review. J Clin Periodontol 2008; (35)8: 255-81.

15. Giannobile WV, Hernandez RA, Finkelman RD, Ryan S, Kiritsy CP, et al. Comparative effects of platelet-derived growth factor-BB and insulin-like growth factor-I, individually and in combination, on periodontal regeneration in Macaca fascicu-laris. J Periodontal Res 1996; (31)5: 301-12.

16. Camelo M, Nevins ML, Schenk RK, Lynch SE and Nevins M. Periodontal regeneration in hu-man Class II furcations using purified recombi-nant human platelet-derived growth factor-BB (rhPDGF-BB) with bone allograft. Int J Periodon-tics Restorative Dent 2003; (23)3: 213-25.

17. Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinirchs JE, et al. Platelet-derived growth factor stimulates bone fill and rate of at-tachment level gain: results of a large multicenter randomized controlled trial. J Periodontol 2005; (76)12: 2205-15.

18. Simion M, Rocchietta I, Kim D, Nevins M and Fiorellini J. Vertical ridge augmentation by means of deproteinized bovine bone block and recom-binant human platelet-derived growth factor-BB: a histologic study in a dog model. Int J Periodon-tics Restorative Dent 2006; (26)5: 415-23.

19. Simion M, Rocchietta I, Dellavia C. Three-dimensional ridge augmentation with xeno-graft and recombinant human platelet-derived growth factor-BB in humans: report of two cases. Int J Periodontics Restorative Dent 2007; (27)2:109-15.

20. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, et al. Effect of para-thyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001; (344)19: 1434-41.

21. Skripitz R, Andreassen TT, Aspenberg P. Strong effect of PTH (1-34) on regenerating bone: a time sequence study in rats. Acta Orthop Scand 2000; (71)6: 619-24.

22. Barboza E, Caula A, Machado F. Potential of recombinant human bone morphogenetic pro-tein-2 in bone regeneration. Implant Dent 1999; (8)4: 360-7.

23. Reddi AH. Bone morphogenetic proteins: from basic science to clinical applications. J Bone Joint Surg Am 2001; (83-A)Suppl 1: S1-6.

24. Wikesjo UM, Huang YH, Polimeni G and Qahash M. Bone morphogenetic proteins: a realistic alternative to bone grafting for alveolar reconstruction. Oral Maxillofac Surg Clin North Am 2007; (19)4: 535-51.

25. Sigurdsson TJ, Lee MB, Kubota K, Turek TJ, Wozney JM, Wikesjo UM. Periodontal repair in dogs: recombinant human bone morphogenetic protein-2 significantly enhances periodontal regeneration. J Periodontol 1995; 66(2): 131-8.

26. Giannobile WV, Ryan S, Shih MS, Su DL, Kaplan PL, Chan TC. Recombinant human os-teogenic protein-1 (OP-1) promotes periodontal wound healing in class III furcation defects. J Periodontol 1998; 69(2): 129-37.

27. Boyne PJ, Lilly LC, Marx RE, Moy PK, Nevins M, Spagnoli DB, et al. De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. J Oral Maxillofac Surg 2005; (63)12:1693-707.

28. Boyne PJ, Marx RE, Nevins M, Triplett G, Lazaro E, Lilly C, et al. A feasibility study evaluating rhBMP-2/absorbable collagen sponge for maxil-lary sinus floor augmentation. Int J Periodontics Restorative Dent 1997; (17)1: 11-25.

29. Triplett RG, Nevins M, Marx RE,Spagnoli DB, Oates TW, Moy PK, et al. Pivotal, randomized, parallel evaluation of recombinant human bone morphogenetic protein-2/absorbable collagen sponge and autogenous bone graft for maxillary sinus floor augmentation. J Oral Maxillofac Surg 2009; (67)9: 1947-60.

30. Tarnow DP, Wallace SS, Testori T, Froum SJ, Motroni A, Prasad HS. Maxillary sinus augmen-tation using recombinant bone morphogenetic protein-2/acellular collagen sponge in combina-tion with a mineralized bone replacement graft: a report of three cases. Int J Periodontics Restor-ative Dent 2010; (30)2: 139-49.

31. Howell TH, Fiorellini J, Jones A, Alder M, Num-mikoski P, Lazaro M, et al. A feasibility study evaluating rhBMP-2/absorbable collagen sponge device for local alveolar ridge preserva-tion or augmentation. Int J Periodontics Restor-ative Dent 1997; (17)2: 124-39.

32. Cochran DL, Jones AA, Lilly LC, Fiorellini JP and Howell H. Evaluation of recombinant human bone morphogenetic protein-2 in oral applica-tions including the use of endosseous implants: 3-year results of a pilot study in humans. J Peri-odontol 2000; (71)8: 1241-57.

33. Barboza EP, Duarte ME, Geolas L, Sorensen RG, Riedel GE, Wikesjo UM. Ridge augmenta-tion following implantation of recombinant hu-man bone morphogenetic protein-2 in the dog. J Periodontol 2000; (71)3: 488-96.

34. Jung RE, Glauser R, Scharer P, Hammerle CH, Sailer HF and Weber FE. Effect of rhBMP-2 on guided bone regeneration in humans. Clin Oral Implants Res 2003; (14)5: 556-68.

35. Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly C, Spangoli D, et al. Randomized study evaluating recombinant human bone morphoge-netic protein-2 for extraction socket augmenta-tion. J Periodontol 2005; (76)4: 605-13.

35. Hart KL, Bowles D. “Reconstruction of alveolar defects using titanium-reinforced porous poly-ethylene as a containment device for recombi-nant human bone morphogenetic protein 2. J Oral Maxillofac Surg 2012; (70)4: 811-20.

36. Misch CM. “Bone augmentation of the atrophic posterior mandible for dental implants using rhBMP-2 and titanium mesh: clinical technique and early results. Int J Periodontics Restorative Dent 2011; (31)6: 581-9.

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Wilcko et al

Background: Tooth-supported stereolitho-graphic surgical guides have shown the high-est degree of accuracy among all types of digital surgical guides. Unfortunately, this type of sur-gical guide is not valid for completely edentu-lous patients and mucosa or bone supported guides are used instead. Mucosa-supported surgical guides have many advantages over bone-supported surgical guides and therefore, more research is needed to improve the accu-racy of the mucosa-supported surgical guide.

Methods: A total of 20 implants were placed into 5 completely edentulous patients. Their lower waxed-up dentures were duplicated to form the radio-opaque prosthesis needed during CT scanning. The stone casts of their lower arch were also scanned using laser scanner. Using SimPlant Pro software, the 3D data were recon-structed and assembled to the optical scan of

the cast. After complete implant planning of the patient data, two mucosa supported surgical guides were created (one using ordinary method and the other one using the modified technique). Both surgical guides were used for implant place-ment followed by CT scanning of the patient. The deviation of the planned 3D implant position and angulation from that of the placed implant position were measured and calculated digitally.

Results: No statistically significant difference could be detected between implants placed by ordinary method and those placed with modified technique in both angular deviation and linear dis-tance at the coronal end of implant in both groups.

Conclusion: Although there was a slight improvement in accuracy with the modi-fied mucosa-supported surgical guide, there was no statistical significant difference.

Accuracy of Implant Placement Using Modified Mucosa-Supported

Steriolithographic Surgical Guide

Dr. Mostafa Omran Hussein1 • Dr. Amr El Karargy2

1. Assistant Professor of Prosthodontics, Faculty of Dentistry, Qassim University. Saudi Arabia

2. Associate Professor of Periodontology, Faculty of Dentistry, Qassim University. Saudi Arabia

Abstract

KEY WORDS: Stereolithographic, digital surgical guide, Simplant, CT registration

The Journal of Implant & Advanced Clinical Dentistry • 25

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26 • Vol. 5, No. 7 • July 2013

IntRODuCtIOnThorough preoperative planning of implant treatment is a prerequisite for a success-ful treatment outcome. The goal of preopera-tive evaluation is to assess both the quantity and the quality of the jaw bone areas to be implanted. Clinical examination provides very limited information on the width and height of the jaw bone and allows neither assessment of critical anatomical structures nor examina-tion of other bony characteristics. These data are, however, essential to improve success-ful treatment outcome in certain areas, they may be obtained from radiographic images.1

A variety of imaging modalities are avail-able for this purpose, although, in the major-ity of cases, cross-sectional imaging seems a prerequisite. These images may be obtained either by conventional spiral tomography or by CT scan. The application of digital fabrica-tion of the surgical guide is considered one precise method practiced for implant place-ment.2-5 Earlier studies concluded that the 3D planning resulted in implant positioning with improved biomechanics and esthetics.6-8 Use of such a system usually removes complica-tions including mandibular nerve damage, sinus perforations, fenestrations or dehiscences.9,10

There are three forms feasible for fabricat-ing surgical guides according to the persisting natural teeth and the surgical technique. The stereolithographic guides could be in the form of tooth supported surgical guide, bone sup-ported surgical guide or mucosa supported surgical guide.11,12 Ozan et al.13 studied the accuracy of these three types of the stereo-lithographic surgical guides to determine the angular and linear deviations at the implant

neck and apex between planned and placed implants. Their results clarified that tooth-supported surgical guides were more accu-rate than mucosa-supported surgical guide followed by bone- supported surgical guide.

Besimo et al.14 assessed the magnitude of error in transferring the planned position of implants from CT scans to a surgical guide. The deviation between the positions of the apex of the proposed implants in cross-sectional CT images and on the corresponding study cast was measured in 77 sites they concluded that the transfer errors noted in their study were not clinically relevant because other factors involved in transferring positional and angular measurements from CT images to the actual surgical area may result in greater errors.

Sarment et al.15 studied in vitro placing of 50 implants into 5 epoxy resin edentulous mandible models. Each epoxy resin mandible received 5 implants in each side. On the right side, 5 implants were inserted using a con-ventional surgical guide, whereas on the left side, 5 implants were inserted using a ste-riolithographic surgical guide. When com-pared with conventional guides, they noted significant improvements in all measure-ments with steriolithographic surgical guides.

The mucosa supported surgical guide is one of the surgical guides designed for com-pletely edentulous patient seeking for implant treatment.12 This sort of surgical guide may requires dual CT scans to retrieve mucosal thickness. The first CT scanning is executed with the patient wearing a scan prosthesis and the second scanning is conducted with the scan prosthesis itself.11,12 The mucosa sup-ported prosthesis has some merits; easier sur-

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The Journal of Implant & Advanced Clinical Dentistry • 27

gical technique, reduced surgical time and less post-operative complications because no flaps were needed.10 The aim of this study was to compare the accuracy of the modi-fied surgical guide with the ordinary mucosa-supported stereolithographic surgical guide.

MAtERIAlS AnD MEthODSA total of 20 implants were placed into 5 com-pletely edentulous patients, based on two tem-plates and four implants for each patient. The study composed of two groups: group I using ordinary mucosa- supported stereolithographic method of surgical guide and group II using a modified surgical guide technique. The patients were selected from the outpatient clinic, Col-lage of Dentistry, Qassim University KSA, with age range 50-60 years according to selected criteria which are based on the validity of these patients to receive implant-tissue supported overdenture.16 All patients should be free from any uncontrolled medical condition, non-smok-ers or less than ten cigarettes per day and did

not receive or scheduled for radio or chemo-therapy. All patients should also have enough bone volume without using any grafts. The residual tissues of both arches for all patients were checked clinically and radiographically.

FABRICAtIOn OF thE SCAn PROSthESIS

Upper and lower complete dentures were scheduled till try-in stage for these patients. After try-in stage, five small holes (3mm diam-eter) were cut on the border of the waxed-up trial denture; three on the facial border and two on the lingual border. At the positions of the holes small metal rods (3 mm x 5mm) were attached to the cast to act as counter part of these holes positions as shown in (Fig.1).

The scanning template was fabricated from clear acrylic (Acrostone self-cure, Acros-tone WIW, England) and barium sulfate as the radiopaque material (10% by weight for the denture base and teeth) by duplicating pre-viously fabricated waxed-up denture (Fig.2).

Figure 1: Conventional mucosa-supported surgical guide over the bone of the mandible spaced by mucosal thickness.

Figure 2: Scan registration using the optical scan (laser scan) of the modified cast. The upper two windows before registration with labeled markers while the lower window showing full registration.

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Ct SCAnnIng OF thE PAtIEntBefore CT scanning, the patient was prepared by making the patient fully supine on the scan-ner table and moves the patient to get gantry tilt zero degree. Make the patient comfortable and instruct him not to move during the proce-dure. For correct alignment, the transaxial CT slice plane should be parallel to the occlusal plane. Ideally, you should determine the occlu-

sal plane while the patient’s scan prosthesis in place inside patient mouth. Standardized CT scanning (GE Medical System/Bright Speed S, USA) procedures were followed for each patient. The scanning template was used dur-ing CT imaging. The following protocol12 was followed: 1) The axial plane was adjusted par-allel to the plane of occlusion, with the Gantry tilt at zero degree for optimum accuracy; 2) the

Figure 3: Modified mucosa-supported surgical guide preview seated on laser scanned model and CT scanned bone of the patient.

Figure 4: An overview of the planned implant overlapped the placed implants.

Figure 5: Deviation of the long axis of the planned (purple) and placed implant (grey) at the coronal end measured by (mm).

Figure 6: Angular deviation between planned (green) and placed implant (grey) measured in (degree).

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The Journal of Implant & Advanced Clinical Dentistry • 29

CT scan was made without inter-arch contact, occluding on a wood stick; 3) the occlusal sur-face of the arch was clearly visible; and 4) the patient was immobilized during the scanning procedure. The slice thickness was 1 mm with a field of view above occlusal plane and below inferior border of the mandible (140-170 mm). A proper image reconstruction algorithm was used to get sharp reformatted images. The bone or high-resolution algorithm is prescribed. Images reconstruction with a 512 x 512 matrix is enough to get proper resolution. The scan-ning previous parameters are repeated for all patients. The small metal rods on the master cast were painted with chalky dye to prevent reflection and noise during laser scanning. The stone master cast carrying the metal rods was then laser scanned using (D-250, 3ShapeA/S, Copenhagen, Denmark) scanner. The scanned data of the cast is stored in the computer to be imported later in the implant planning software.

CREAtIOn OF thE StEREOlIthOgRAPhIC

SuRgICAl guIDESThe saved dicom images of the CT were imported into the SimPlant Pro software(SimPlant Pro, Materialise Dental; Belgium) to reconstruct 3D data. The second CT scan of the radiographic guide (scan prosthesis) was then registered with the first CT scan to retrieve the mucosal thickness using segmenta-tion registration wizard of the software.17 Plan-ning for implant placement was started using ordinary method by placing four implants (Zim-mer dental tapered screw-vent MTX; Swit-zerland) at the parasymphyseal area of the mandible. Implants position and orientation checked for parallelism as much as possible. All steps for planning the case were followed till exporting the 3D STL (file format) of the mucosa supported surgical guide (Fig. 3).

The modified surgical guide was created

Figure 7: Total mean errors: angular deviation. Figure 8: Total mean errors: linear distance.

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after importing the optical scan (3D scan) of the cast followed by using scan registration module of the SimPlant Pro software to place the cast in the same relation to the scan template using the previously formed holes as markers (Fig.4). Finally, the 3D STL file of the modified surgical guide was also exported (Fig. 5). Both exported surgical guide were sent to surgical guide man-ufacturing center (3D Diagnostix co. Cairo; Egypt) to be imported to the Steriolithographic machine to form the final surgical guides.

IMPlAnt PlACEMEntEach patient had two surgical guides before their surgical operation to place the prede-termined 4 mandibular implants. Two of these implants were inserted using the conven-tional surgical guide and the remaining two implants with the modified surgical guide.

POSt-OPERAtIvE Ct SCAnnIng AnD MAtChIng PROCEDuRES

After inserting all implants for all patients, all patients were rescanned using CT scan machine with the same parameters used for the first scan. CT scan images after implanta-tion were registered to the pre-implantation CT images (first scan) using the segmentation registration wizard. After that the 3D models of the implant fixtures were constructed.

The distance between the long axis (linear distance) of the planned and placed implant at the coronal end was measured in mm, more-over the angle of deviation between their long axes was also measured in degrees (Figs. 6-8).All data are collected and categorized into two groups for both type of surgical guides.

StAtIStICAl AnAlYSISThe study results were expressed by mean values and standard deviations (SD), Inde-pendent-Samples T-Test and P-values less than 0.05 were considered statistically signifi-cant. The data were analyzed using an SPSS (Version17) statistical program package.

RESultSThe differences between the placed position of each implant and its position in the planning were analyzed in Table 1. In the first group using the ordinary method of surgical guide, the total mean errors for angular deviation of the long axis between planned and placed implant were 3.48° (range 2.64° - 5.1°, SD 0. 0.92) and 0.89 (range 0.64-1.21, SD 0.17) for linear distance in (mm).

In the second group using the modified sur-gical guide technique, the total mean errors between planned and placed implant were 3.07° (range 2.1°– 4.63°, SD 0.85) for angu-lar deviation of the long axis and 0.82 (range 0.6-1.00, SD 0.13) for linear distance in (mm), No statistically significant differences were found between the two groups (Figs. 9,10).

DISCuSSIOn Advanced technology in computer-guided implan-tology software allows for osteotomy site prepa-ration and implant positioning to be guided by a computer rather than intuitively driven.2 This pro-cess is a prosthetically driven approach to implant treatment planning and requires the use of scan-ning appliances designed to transfer the pros-thetic outcome information to CT study.2,3 Through the use of computer software (for example: Sim-Plant, Materialise) it is now possible to precisely transfer a prosthetically directed treatment plan

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The Journal of Implant & Advanced Clinical Dentistry • 31

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to a stereolithographic medical model for con-struction of surgical drilling guides.6,7 Such a procedure has promising clinical results,18-20 even with a medium-term follow-up,21 short-ened surgical times, less invasive surgery, and less postoperative discomfort and pain.22-25

The findings of this investigation showed no statically significant difference between ordinary method and modified technique in both angular deviation and linear deviation of the implant neck in all placed implants although the means errors were less in modified protocol in both angu-lar deviation and linear deviation of the implant neck than ordinary method (it was 0.82 and 3.07º in modified protocol, 0.89 and 3.48º ordi-nary method). However these results are more

close to the angular and linear deviations of the tooth supported surgical guide (0.87 mm and 2.9º) as measured by Ozan et al.13 These results also agreed with many researches however their points of measurements were different.26-30

Although flapless surgery is quite often used in daily practice, very few papers on accuracy are available when using stereolithographic mucosal-supported surgical guides for full jaw rehabilita-tion in maxilla or mandible. Additionally, the study designs reporting on different supporting surfaces (dental and mucosal), different implant systems or designs (standard oral implants and zygoma/ pter-ygoid implants) and the rather limited number of implants included in the papers lead to the conclu-sion that the evidence on accuracy is lacking.13,26

Table 1: Dimensional Measurements of the Actual Position of Each Implant and its Position in the Planning

Linear Distance in mm Angular Deviation in Degree

Mucosa-supported Modified Surgical Mucosa-supported Modified surgical Guide Guide Guide Guide

Group i Group ii Group i Group ii

Mean 0.89 0.82 3.48 3.07

Standard 0.17 0.13 0.92 0.85 Deviation

Maximum 1.21 1.00 5.10 4.63

T-Test 1.13 1.031

P-Value 0.275 0.316

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Many researchers studied the use of dif-ferent types of surgical guides seeking for accurate placement of implants. Most of the results clarified that the use of tooth-sup-ported surgical guide had the most precise placement than the other types.29-31 Invivo and invitro studies measured the amount of devia-tions between the planned implants (virtu-ally placed) and the final placed ones. The values of error varied between each other and especially between different subjects.26, 30-33

The tooth-supported surgical guide showed high accuracy results when com-pared to the bone-supported and even mucosa-supported surgical guide.13 This type of guides requires only one CT scan of the patient with the scan prostheses and another optical scan (laser scan) of the patient cast. However, this type of surgical guide could not be used for completely edentu-lous patients.12,14,15 As expected the source of this accuracy is the accuracy of the laser

scanned surface than the CT scanned surface.All previous data indicated that a substan-

tial deviation is found between virtually planned and in vivo placed implants. This means that there are some sort of inevitable errors that could or could not evaluated. These errors may be correlated to the surgical guide itself, metallic sleeves of the guide, the way by which the guide fixed during drilling and the type of tissue at which the guide was supported.

Another system-inherent cause of devia-tions may be the discrepancy between guide sleeve and bur or implant mount of about 0.15 mm with the present system. With respect to a different template (SurgiGuidet, Materialise Dental, Leuven, Belgium), Valente et al.34 quan-tified the gap between the internal diameter of the guide sleeve and the respective bur with 0.15 – 0.2mm. However, a certain discrepancy between the guiding elements is required for mechanical reasons to ensure adequate implant bed preparation and implant insertion.35- 37

Photo 1: Mandibular stone cast with attached five small rods, three from facial side and two from lingual.

Photo 2: Scan prostheses in place over the modified cast.

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The Journal of Implant & Advanced Clinical Dentistry • 33

In order to fabricate accurate scan template for mucosa-supported surgical guide, absolute contact between mucosa and the fitting surface of the scan prostheses is mandatory. So any areas such as areas of undercuts may lead to an error because it will form a space or air filling volume below the scan prostheses. These areas changed the surface topography of the created 3D object.17 It also requires accurate registra-tion between the CT of the patient with the scan prosthesis and the scan prosthesis itself.12,13,17

Vasak et al30 also exhibit interesting results towards a correlation between implant position and arch type and accuracy of implant place-ment using digital guide, they are also correlate mucosal thickness as an error initiating factor. These results confirm the hypothesis of flexible support and their consequences on accuracy.

Factors that may initiate errors in the pre-operative CT scans may also include an impre-cisely located CT template or artifacts due to minimal movements of the patient during image data collection.36,38 With regard to the registration error, Vasak et al30 found an aver-age fusion inaccuracy of 0.14 mm with a maximum deviation of 0.21 mm. It was also reported a planning-phase-related inaccuracy of an average of 0.32–0.49 mm. The poten-tial manufacturing inaccuracy of the stereo-lithographically manufactured implantation template is within a range of 0.1–0.2mm.19

That second CT scan of the prostheses requires radiolucent carrier that could carry the prostheses in the same position as it was in the first scan.17 In addition, the patient was asked to fix the prostheses during CT scan through biting moderately and equally bilat-erally on soft radiolucent object which may

result in micromovements because of soft tis-sue flexibility. This means that this protocol is a sensitive technique and some errors may be expected. The previous finding was agreed with Ozan et al.25 who clarified that the errors in mucosa-supported surgical guide may be inher-ited or unavoidable due to mucosal flexibility.

Cast scanning using laser scanner pro-vide more accurate, high resolution 3D model with more surface details with no artifacts. The quality of the model is quietly higher than that received from CT scanning especially for both areas with soft tissues and other areas with metallic artifacts if present.24,25

The use of mucosa-supported surgical guide appeared to have many challenging issues to get precise surgical guide and some errors seems to be technique inherited. On the other hand, these errors were cured somewhat in the tooth supported surgical guide. The use of the modified technique enabled the use of mucosa-supported surgical guide with all its advantages and reducing the error ratio by getting the ben-efits of the tooth-supported surgical guide.

The slight difference in the results of the present study may be small enough to mea-sure accurately after segmenting the actual implant 3D model which is also same error expected during segmenting and building 3D model of the teeth. These type of error that require using optical scan of the cast as a sup-porting object instead of using CT scan of the teeth during manufacturing tooth-supported surgical guide.12 Now it is clear that whatever the modification, mucosa-supported surgi-cal guide has a sensitive technique with minor inherited error could be evoked by the muco-sal resiliency even when using fixation screw.

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Especially; as in the present study; when two guides used a minor change in position could be occurred. Therefore, slight compression is recommended during adding fixation screws.

COnCluSIOnAlthough there was a slight improvement in accuracy measured after modifying the mucosa-supported surgical guide, the dif-ferences were not statistically significant. The modified surgical guide, however, was shown to be an acceptable alternative ●

Correspondence:Dr. Mostafa Omran HusseinColledge of dentistry, Qassim UniversityAl-mulaidah, Buraidah postal code: 51452P.O. box: 6700QassimKSAPhone#: +966 531206746 +966 63800050E-mail: [email protected] [email protected]

ATTENTION PROSPECTIVE AUTHORS

JIACD wants to publish your article!

The Journal of Implant & Advanced Clinical Dentistry

For complete details regarding publication in JIACD, please refer to our author guidelines at

the following link: http://www.jiacd.com/authorinfo/author-guidelines.pdf

or email us at: [email protected]

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The Journal of Implant & Advanced Clinical Dentistry • 35

DisclosureThe authors report no conflicts of interest with anything mentioned in this article.

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planning and assessment of endosseous oral implants. Berlin: Springer-Verlag, 1998.

2. Shaikh A, Chandler B, Reynolds A. Implant dentistry in the digital dental world. Implantology in Practice 2010; 2: 112-118.

3. Strub J R, Rekow E D, Siegbert, W. Computer-aided design and fabrication of dental restorations, Current systems and future possibilities. JADA 2006; 137: 1289-96.

4. Teruaki I. A virtual environment approach for planning implant placement. Int J Adv Manuf Technol. 2006; 30: 974–978.

5. Ronald E J, David S, Jeffrey G, Marcel Z, Christoph H F, Ali T. Computer technology applications in surgical implant dentistry. A Systematic Review. Int J Oral Maxillofac Implants 2009; 24: 92–109.

6. Wittwer G, Adeyemo W L, Schicho K, et al. Prospective randomized clinical comparison of 2 dental implant navigation systems. Int J Oral Maxillofac Implants 2007; 22: 785-791.

7. Sanna A M, Molly L, Van Steenberghe D. Immediately loaded CAD-CAM manufactured fixed complete dentures using flapless implant placement procedures: A cohort study of consecutive patients. J Prosthet Dent 2007; 97: 331-338.

8. Verstreken K, Van Cleynenbreugel J, Marchal G, et al. Computer-assisted planning of oral implant surgery: A 3-dimensional approach. Int J Oral Maxillofac Implants 1996; 11: 806-813.

9. Nickenig H J, Eitner S. Reliability of implant placement after virtual planning of implant positions using cone beam CT data and surgical (guide) templates. J Craniomaxillofac Surg 2007; 35: 207-215.

10. Anthony R, Sean G. Planning dental implants- What are the options? Scottish Dentist 2001; 53: 302-310.

11. Tardieu P B, Vrielinck L, Escolano E. Computer-assisted implant placement. A case report: Treatment of the mandible. Int J Oral Maxillofac Implants 2003; 18: 599-607.

12. Materialize Dental. Surgiguide cook book & scanning protocol for simplant and surgiguide. Available at http://www.materialisedental.com/Dental3D. Accessed January 3, 2011.

13. Ozan O, Turkyilmaz I, Ersoy A E, McGlumphy E, Rosenstiel S F. Clinical accuracy of 3 different types of computed tomography-derived stereolithographic surgical guides in implant placement. J Oral Maxillofac Surg 2009; 67: 394-401.

14. Besimo C E, Lambrecht J T, Guindy J S. Accuracy of implant treatment planning using template-guided reformatted computed tomography. Dentomaxillofac Radiol 2000; 29: 46-55.

15. Sarment D P, Sukovic P, Clinthorne N. Accuracy of implant placement with a stereolithographic surgical guide. Int J Oral Maxillofac Implants 2003; 18: 571-577.

16. Misch C E. Contemporary Implant Dentistry, 3rd ed. Elsevier Health Sciences; 2008: 296-297.

17. SimPlant Dental. Guide line for Dual scan protocol CT; . Available at http://www.simplantacademy.org/index.php/. Accessed January 4, 2011.

18. Van Steenberghe D, Glauser R, Blomback U, Andersson, M, Schutyser F, Pettersson A,Wendelhag I. A computed tomographic scan-derived customized surgical template and fixed prosthesis for flapless surgery and immediate loading of implants in fully edentulous maxillae: A prospective multicenter study. Clinical Implant Dentistry and Related Research 2005; 7: 111– 120.

19. Van Steenberghe D, Naert I, Andersson M, et al. A custom template and definitive prosthesis allowing immediate implant loading in the maxilla: A clinical report. The International Journal of Oral and Maxillofacial Implants 2002; 17: 663–670.

20. Ganz S. D. Use of stereolithographic models as diagnostic and restorative aids for predictable immediate loading of implants. Practical Procedures and Aesthetic Dentistry 2003; 15: 763–771.

21. Sanna A M, Molly L, Van Steenberghe D. Immediately loaded CAD–CAM manufactured fixed complete dentures using flapless implant placement procedures: a cohort study of consecutive patients. Journal of Prosthetic Dentistry 2007; 97: 331–339.

22. Vrielinck L, Politis C, Schepers S, Pauwels, M, Naert I. Image-based planning and clinical validation of zygoma and pterygoid implant placement in patients with severe bone atrophy using customized drill guides. Preliminary results from a prospective clinical follow-up study. The International Journal of Oral and Maxillofacial Surgery 2003; 32: 7–14.

23. Malevez C, Abarca M, Durdu F, Daelemans P. Clinical outcome of 103 consecutive zygomatic implants: a 6–48 months follow-up study. Clinical Oral Implants Research 2004; 15: 18–22.

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26. D’haese J, Van De Velde T, Komiyama A, Hultin M, De Bruyn H. Accuracy and Complications Using Computer-Designed Stereolithographic Surgical Guides for Oral Rehabilitation by Means of Dental Implants: A Review of the Literature. Clinical Implant Dentistry and Related Research 2012; 14: 321-335.

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28. Fitzgerald M, O’Sullivan M, O’Connell B, Houston F. Accuracy of Bone Mapping and Guided Flapless Implant Placement in Human Cadavers Using a Model-Based Planning Procedure. Int J Oral Maxillofac Implants 2010; 25: 999–1006.

29. Van Steenberghe D, Malevez C, Van Cleynenbreugel J, Bou Serhal C, Dhoore E, Schutyser F, Suetens P, Jacobs R. Accuracy of drilling guides for transfer from three-dimensional CT-based planning to placement of zygoma implants in human cadavers. Clin. Oral Impl. Res 2003; 14: 131–136.

30. Vasak C, Watzak G, Gahleitner A, Strbac G, Schemper M, Zechner W. Computed tomography-based evaluation of template (NobelGuidet)-guided implant positions: a prospective radiological study. Clin. Oral Impl. Res. 2011; 22: 1157–1163.

31. Van Assche N, Van Steenberghe D, Guerrero M E, et al. Accuracy of implant placement based on pre-surgical planning of three-dimensional cone-beam images: A pilot study. J Clin Periodontol 2007; 34: 816-821.

32. Ruppin J, Popovic A, Strauss M, Spu¨ntrup E, Steiner A, Stoll C. Evaluation of the accuracy of three different computer-aided surgery systems in dental implantology: optical tracking vs. stereolithographic splint systems. Clin Oral Impl Res. 2008; 19: 709–716.

33. George A, Alan L, Samantha D, Marc L. Computer-Guided Implant Dentistry for Precise Implant Placement: Combining specialized Stereolithographically Generated Drilling Guides and Surgical Implant Instrumentation. Int J Periodontics Restorative Dent. 2010; 30: 275–281.

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36. Dreiseidler T, Neugebauer J, Ritter L, Lingohr T, et al. Accuracy of a newly developed integrated system for dental implant planning. Clinical Oral Implants Research 2009; 20: 1191–1199.

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Wilcko et al

Background: Recently, block allografts have been reported for successful implant site devel-opment, thus eliminating need for a second surgical site. One such material is Demineral-ized freeze dried bone block allograft (DFDBA). The purpose of this study was to evaluate the effectiveness of localized ridge augmenta-tion with block allograft (DFDBA) followed by one stage early loading implant placement.

Methods: Fourteen patients aged 19 to 39 years and requiring single tooth replacement in the maxillary anterior region with Seibert’s class I ridge defect were recruited to participate in the study. The block allografts were shaped to fit the defect, rehydrated in sterile saline, stabilized with fixation screws prior to soft tis-sue closure. Four months later, implants were

placed in the previously augmented site by one stage early loading protocol. Both soft and hard tissue ridge defects were recorded at 4 sites via: crest, 1mm, 3mm, and 5mm apical to crest.

Results: At 4 months re-entry all grafted sites appeared integrated with clinically visible bleed-ing following removal of screws. Mean gain in alveolar ridge width was 2.6 ± 0.6mm and 3.35 ± 0.77mm for soft and hard tissue respec-tively. At 1 one year implant survival was 85.7%.

Conclusion: Based on the results of this study, it can be concluded that one stage early load-ing of implants may possible develop into a predictable treatment modality after local-ized ridge augmentation with block allograft.

Success of Early Loading Dental Implants on Deficient Anterior Maxillae Augmented

with Block Allografts

Capt (Dr) Varun Choudhary1 • Col (Dr) S K Rath2

1. Dental Officer, Dept. of Periodontology, Army Dental Centre (Research & Referral), Delhi Cantt-110010

2. Senior Specialist, Dept. of Periodontology, Army Dental Centre (Research & Referral), Delhi Cantt-110010

Abstract

KEY WORDS: Block allograft, ridge augmentation, dental implants, early loading

The Journal of Implant & Advanced Clinical Dentistry • 37

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38 • Vol. 5, No. 7 • July 2013

INTRODUCTIONSignificant alveolar bone loss causing ridge defects are a common finding in partially or completely edentulous patients. Localized alveolar ridge defects can result from tooth extraction, periodontal disease, trauma, or development defects. These ridge defects can result in poor esthetics and insufficient bone volume for dental implant placement. There-fore, ridge augmentation becomes necessary to achieve harmonious balance among func-tional, biologic and esthetics before implant placement. Various techniques have been proposed to correct alveolar ridge deformi-ties including grafting with autogenous bone blocks from the patient’s mandibular sym-physis,1,2 ramus,3 iliac crest,4 and head of the tibia.5 However, donor site morbidity, increased operating time, deficiencies in the quality and/or quantity of available bone, limitations in sizes and shapes of available grafts and the potential for intraoperative and postoperative complications are clinical concerns associ-ated with use of autogenous bone blocks.6,7,8,9

Recently, preliminary case reports by Lyford et al.,10 Keith,11 Petrungaro and Amar12 sug-gest that block allograft may be an acceptable alternative to the autogenous bone block graft for successful augmentation of deficient alveo-lar ridge. The advantages of block allograft include a ready availability with unlimited supply, extremely low antigenic potential and unblem-ished safety record in dentistry.13 Demineral-ized freeze dried bone allografts (DFDBA) have been in clinical use for over 40 years. These bone allografts are primarily considered to be osteoconductive providing a scaffold for migrating cells. In addition, the process of

demineralization exposes the bone morpho-genetic proteins (BMP) present in the tissue, which has capacity to induce a phenotypic change of host pluripotent cells into osteo-blast and cause orderly sequence of endochon-dral osteogenesis throughout the grafted area.

There is still insufficient data regarding the short term and long term outcome of implants placed in augmented sites. However, recent systematic review by Hammerle (2002)14 concluded that implant survival varies from 79% to 100% and indicated that more than 90% survives after at least 1 year of load-ing. These results seem comparable to non augmented implant sites. The purpose of this study was to evaluate the effectiveness of block allograft (DFDBA) for localized ridge aug-mentation followed by one stage early loading implant placement in maxillary anterior region.

MATERIAL AND METHODSFourteen patients aged 19 to 39 years and requiring single tooth replacement in maxil-lary anterior region with Seibert’s class I ridge defect were recruited to participate in the study. A comprehensive evaluation of each patient was performed to assess systemic health and the periodontal status of all remaining teeth. Each patient was determined to be in good health, and none reported a positive history of smok-ing. At first appointment patient education as well as oral hygiene instructions were given. After explanation of the study, including ben-efits, risks, and alternative treatments, patients signed an Institutional Review Board-approved consent form. Ridge defect was recorded with the help of Williams graduated periodontal probe (Hu-Friedy) for both soft and hard tis-

Choudhary et al

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The Journal of Implant & Advanced Clinical Dentistry • 39

sue (intrasurgical) at 4 sites via: at Crest, 1mm, 3mm and 5 mm apical to the crest of defect by placing one probe horizontally across the labial surface parallel to the crest of the ridge and other perpendicular to it at base line and at 4 months after ridge augmentation surgery during implant placement. Standardized intra-

oral periapical radiograph was obtained after implant placement and again at 1 year dur-ing recall visit. To assess the changes at the interproximal alveolar crestal bone height, the distance from the implant shoulder to the high-est coronal point of crestal bone was mea-sured both at the mesial and distal aspect of

Figure 1: Initial ridge defect following cortical penetrations.

Figure 2: Block allograft trimmed for placement with pre-drilled screw.

Figure 3: Fixated block allograft with DFDBA particulate graft.

Figure 4: Primary closure of surgical site.

Choudhary et al

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40 • Vol. 5, No. 7 • July 2013

each implant and was expressed in millimeter.

SURgICAL PROCEDUREPrior to the surgical procedure, the patients were instructed to rinse with 10 ml of a 0.12% chlorhexidine gluconate solution for 30 sec-onds. Briefly after induction of local anesthe-sia (block and infiltration using 2% lidocaine

with 1:100,000 epinephrine), a crestal incision slightly palatal to the crest of edentulous site and a vertical releasing incision extending into the vestibule was made (Figure 1). The papillae of the adjacent teeth was included in the flap design to allow maximum exposure of surgical site enabling controlled placement of fixation screws and assisting with predictable wound closure. Full thickness mucoperiosteal flap was elevated bucally. Recipient site was contoured to allow the graft to be placed into position for maximum bony contact and graft stability. Mul-tiple perforations were made through the corti-cal plate with half millimeter round bur to ensure broadest communication possible between the grafted bone and bone marrow cavity and to induce revascularization and influx of growth factors and platelets to enhance bone neogen-esis. Block allograft DFDBA (Tata memorial hospital tissue bank, Mumbai) was hydrated with a sterile saline solution for atleast 30 min-utes before use. Then it was trimmed with a

Figure 5: Surgical augmentation site at 4 months healing. Figure 6: Placement of dental implant at augmented surgical site.

Figure 7: Final restoration 15 days after implant placement.

Choudhary et al

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The Journal of Implant & Advanced Clinical Dentistry • 41

fissure bur in a high speed handpiece with a copious irrigation to fit the precise dimension of the defect and to ensure adequate width for implant placement. The graft was thoroughly rinsed with a sterile saline to remove residual bone particles. The prepared block allograft and recipient bed was predrilled to accommo-date a 1.5 mm×8mm titanium screw (Ortho-max) (Figure 2). Fixation screw was placed in an oblique fashion so as not to induce stress fracture in the bone block allograft. DFDBA particulate allograft was placed mesially and distally to create a gradually following architec-ture (Figure 3). Buccal flap was undermined and releasing incision of the periosteum was made to permit primary closure over the bone graft. Special attention was given to ensure tension free closure. Flap was closed with multiple interrupted sutures (Figure 4). Post-operatively, patient was placed on Amoxicillin 500mg, three times a day for 5 days, Combiflam three times a day for 5 days and Chlorhexidine 0.2% mouth rinse 10ml twice daily for 7 days. Sutures were removed at 2 weeks. Provisional removable prosthesis used during entire heal-ing period was adapted so as not to impinge on the block graft and result in wound dehis-cence and bone resorption. Patients were seen weekly during first month postsurgery and monthly thereafter until second stage surgery to assess soft tissue status for any complication.

Re-entry surgical procedure for implant placement was performed after 4 months. All sites appeared integrated and clinically vis-ible blood was seen following removal of the fixation screw (Figure 5). The types of implants used were Hi-tech implants (TRX-OP) by early loading protocol. Briefly after induction of

local anesthesia, a crestal incision was made along the crest of the ridge but slightly pala-tally, bisecting the existing keratinized mucosa but without splitting the adjacent papillae, ver-tical releasing incision was made extending to the vestibule. A full thickness flap was raised buccally and palatally exposing the underlined ridge of the implant site. A surgical drill guide was used for the precise placement of the pilot drill. After pilot drill application, the implant site was prepared with the corresponding size of parallel drill. The implants were placed in the recipient site by means of an insertion device, and a torque driver set at 35 Ncm was used to evaluate primary stability of implant. The implant neck was positioned at the crestal bone level or slightly submerged (Figure 6). Within 15 days, a permanent restoration was placed (Figure 7). The patients were recalled at 1 year following permanent restoration. At recall visit clinical & radiographic measure-ments recorded preoperatively were repeated.

RESULTSThe age range of selected patients was between 19 and 39 years with the average age being 25.8 years. Out of 14 patients, 11 patients had maxillary central incisors missing and 3 had maxillary lateral incisors missing, which were replaced by 14 Hi- tech implants by early loading protocols, along with localized ridge augmentation procedure with block allograft.

During the course of the study, wound healing was uneventful. No implants had to be removed. None of the selected patients had dropped out before the termination of the study. Two implants had clinical mobil-ity at 1 year recall due to periapical infection.

Choudhary et al

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42 • Vol. 5, No. 7 • July 2013

Table 1: Mean Soft Tissue Alveolar Ridge Width at Baseline and 4 Months Post Surgery (mm ± SD)

Sr. No. Recipient Site Alveolar Ridge Defect Width

At 4 Month Alveolar RIdge At Base Line Post Surgery Width Gain

1 21 3.25 1.25 2

2 11 2.75 0.5 2.25

3 12 2.75 0.5 2.25

4 11 3 0 3

5 11 2.5 0.5 2

6 11 3.5 0 3.5

7 12 2.75 0 2.75

8 11 2.75 0.25 2.5

9 21 3.25 0.25 3

10 11 3.5 0.25 3.25

11 21 2.25 0.25 2

12 22 4.25 0.75 3.5

13 21 3 0.5 2.5

14 11 2 0 2

Mean ± SD 2.96 ± 0.57mm 0.35±0.34mm 2.60±0.6mm S

S -Statistically significant (P < 0.05)

Choudhary et al

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The Journal of Implant & Advanced Clinical Dentistry • 43

Table 2: Mean Hard Tissue (Intra Surgical) Alveolar Ridge Defect Width at Baseline and 4 Months Post Surgery (mm ± SD)

Sr. No. Recipient Site Alveolar Ridge Defect Width

At 4 Month Alveolar RIdge At Base Line Post Surgery Width Gain

1 21 3.25 0.75 2.5

2 11 3 0.5 2.5

3 12 3.75 0.25 3.5

4 11 3 0 3

5 11 3 0 3

6 11 4.25 0.25 4

7 12 3.25 0.5 2.75

8 11 4.25 0.5 3.75

9 21 3.5 0.25 3.25

10 11 3.5 0.5 3

11 21 3.5 0.25 3.25

12 22 6 1 5

13 21 5.75 1 4.75

14 11 3 0.25 2.75

Mean ± SD 3.78 ± 0.97mm 0.42±0.31mm 3.35±0.77mm S

S -Statistically significant (P < 0.05)

Choudhary et al

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44 • Vol. 5, No. 7 • July 2013

Mean Level of Mean Level of Crestal Bone at Crestal Bone at 1 Year After Implant Differences Surface Baseline Placement (Mean Bone Loss)

Mesial 0.21 ± 0.42mm 0.57 ± 0.75mm 0.35 ± 0.49mm S

Distal 0.42 ± 0.75mm 1.14 ± 0.77mm 0.71 ± 0.61mm S

Table 3: Mean Radiographic Crestal Bone Level at Implant Site on Mesial and Distal Surfaces at Baseline and at 1 Year After Implant Placement (Mean ± SD)

S -Statistically significant (P < 0.05)

Mean soft tissue alveolar ridge defect width was 2.96 ± 0.57 mm at baseline and reduced to 0.35 ± 0.34 mm, at 4 months after ridge aug-mentation with mean gain in alveolar ridge width of 2.6 ± 0.6mm (Table 1). Mean hard tissue alveolar ridge defect width was 3.78 ± 0.97 mm at baseline and reduced to 0.42 ± 0.31 mm, at 4 months during implant placement with mean gain in alveolar ridge width of 3.35 ± 0.77 mm (Table 2). When comparison was made between mean alveolar ridge defect width at baseline and at 4 months after ridge augmentation by using student’s paired t-test, there was a statis-tical significant mean gain in alveolar ridge width

Radiographic crestal bone level of mesial and distal surfaces of implants and bone loss at 1 year are presented in Table 3. The mean level of bone at mesial surface at base-line was 0.21 mm, and at 1 year it increased to 0.57 mm with mean bone loss of 0.35 mm (Table 3). The mean level of bone at distal sur-face at baseline was 0.42 mm, and at 1 year it

increased to 1.14 mm with mean bone loss of 0.71 mm (Table 3). Mean bone level at base-line when compared with mean bone level at 1 year by using Student’s paired t-test, there was a statistical significant bone loss at 1 year.

DISCUSSIONRidge augmentation has become a standard procedure for patients who otherwise would have insufficient bone for implant placement in a more ideal position. The results showed that localized ridge augmentation procedure using block allograft (DFDBA) four months prior to implant placement can be a suitable bone replacement graft for the augmenta-tion of localized alveolar ridge defects. There was statistically significant increase in ridge width, facilitating implant placement in areas previously judged to be narrow and, that func-tional loading of implants as early as 15 days resulted statistically significant implant stabil-ity using clinical and radiographic measures.

Choudhary et al

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The Journal of Implant & Advanced Clinical Dentistry • 45

The mean gain in soft and hard tissue measurement of alveolar ridge defect width was 2.6 mm and 3.35 mm respectively. Simi-lar observation has been made in previous studies using different type of bone block. Chaipasco et al.15 found increase in alveolar ridge width from 2.7mm to 4 mm after 4 to 8 months of healing by using autogenous block graft. Pendarvis and Sandifer16 reported mean gain of ridge width of 3.0 to 3.2mm with indi-vidual gain upto 7mm at 4 months re-entry by using block allograft. Recently, Peleg et al.17 reported a mean horizontal augmentation of 3.7 mm after 3 to 4 months of healing period using corticocancellous allogenic bone block.

The survival rate of implants used in this study was 85.7% at 1 year follow-up (12 out of 14 implants). De Rouck et al.18 assessed implant survival rate, and aesthetic outcome 1 year after immediate placement and provision-alization of single-tooth implants in the maxil-lary anterior region and reported 97% success rate in 30 patients. Norton19 reported 94.4% survival rate for immediately loaded implants with observation period of 20.3 months (range 13-30 months) after implant placement.

The mean crestal bone loss at 1 year was 0.35mm and 0.71mm on mesial and distal surface of implant respectively, are compa-rable with previous reported studies. Kan et al.20 reported in immediately placed group, the marginal bone loss of 0.87mm after provi-sionalization. Turkyilmaz et al.21 reported the average marginal bone loss of 0.7mm for one stage implant at one year recall. Bone loss around implants occurred mostly in first year after surgery, as reported by Weber et al.,22 who showed that a large percentage of initial

bone loss occurred during the first month in one stage implant. After the first year of func-tion, an immediate restoration did not seem to cause a greater average amount of bone loss.

CONCLUSIONFrom the analysis of the results and within the limitations of the present study it can be con-cluded that one stage early loading of implants may possibly develop into a predictable treat-ment modality after localized ridge augmentation with block allograft by reducing the number of surgical procedures required. Further well con-trolled study with large sample size is needed to confirm findings of the present study ●

Correspondence:Capt Varun Choudhary, Dept of Periodontics, Army Dental Centre (Research & Referral),Delhi Cantt-110010 Tele No: Mob: 9654929710 (O) 011-23338465Email: [email protected]

Choudhary et al

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46 • Vol. 5, No. 7 • July 2013

Choudhary et al

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DisclosureThe authors report no conflicts of interest with anything mentioned in this article.

References1, Pikos MA. Facilitating implant placement with chin grafts as donor sites for

maxillary bone augmentation--Part I. Dent Implantol Update 1995;6(12):89-92.2. Pikos MA. Chin grafts as donor sites for maxillary bone augmentation--Part II.

Dent Implantol Update 1996;7(1):1-4.3. Misch CM, Misch CE, Resnik RR, et al. Reconstruction of maxillary alveolar

defects with mandibular symphysis grafts for dental implants: A preliminary procedural report. Int J Oral Maxillofac Implants 1992;7:360-6.

4. Lekholm U, Wannfors K, Isaksson S, Adielsson B. Oral implants in combination with bone grafts. A 3-year retrospective multicenter study using the Brånemark implant system. Int J Oral Maxillofac Surg. 1999 ;28(3):181-7.

5. Buser D, Brägger U, Lang NP, Nyman S. Regeneration and enlargement of jaw bone using guided tissue regeneration. Clin Oral Implants Res 1990 ;1(1):22-32.

6. Di Stefano DA, Artese L, Iezzi G, et al. Alveolar ridge regeneration with equine spongy bone: a clinical, histological, and immunohistochemical case series. Clin Implant Dent Relat Res 2009;11(2):90-100.

7. Ericsson I, Randow K, Nilner K, Peterson A. Early functional loading of Branemark dental implants: 5-year clinical follow-up study. Clin Implant Dent Relat Res 2000;2(2):70-7.

8. Fritz ME, Lemons JE, Jeffcoat M, Braswell LD, Reddy M. Evaluation of consecutively placed unloaded root-form and plate-form implants in adult Macaca mulatta monkeys. J Periodontol 1994;65(8):788-95.

9. Gutta R, Waite PD. Outcomes of calvarial bone grafting for alveolar ridge reconstruction. Int J Oral Maxillofac Implants 2009;24(1):131-6.

10. Lyford R H, Mills M P, Knapp C I, Scheyer E. T, Mellonig J T. Clinical evaluation of freeze-dried block allografts for alveolar ridge augmentation: A case series. Int J Periodontics Restorative Dent 2003;23:417–25.

11. Keith J. Daulton. Localized ridge augmentation with a block allograft followed by secondary implant placement: A case report. Int J Periodontics Restorative Dent 2004;24:11–7.

12. Petrungaro PS, Amar S. Localized ridge augmentation with allogenic block grafts prior to implant placement: case reports and histologic evaluations. Implant Dent 2005;14(2):139-48.

13. Mellonig JT. Donor selection, testing, and inactivation of the HIV virus in freeze-dried bone allografts. Pract Periodontics Aesthet Dent 1995;7(6):13-22

14. Hammerle CH, Jung RE, Feloutzis A. A systematic review of the survival of implants in bone sites augmented with barrier membranes (guided bone regeneration) in partially edentulous patients. J Clin Periodontol 2002;29 Suppl 3:226-31

15. Chiapasco M, Abati S, Romeo E, Vogel G. Clinical outcome of autogenous bone blocks or guided bone regeneration with e-PTFE membranes for the reconstruction of narrow edentulous ridges. Clin Oral Implants Res 1999; 10(4):278-88.

16. Pendarvis WT, Sandifer JB. Localized ridge augmentation using a block allograft with subsequent implant placement: a case series. Int J Periodontics Restorative Dent 2008; 28(5):509-15.

17. Peleg M, Sawatari Y, Marx RN, et al. Use of corticocancellous allogeneic bone blocks for augmentation of alveolar bone defects. Int J Oral Maxillofac Implants 2010; 25(1):153-62.

18. De Rouck T, Collys K, Cosyn J. Immediate single-tooth implants in the anterior maxilla: a 1-year case cohort study on hard and soft tissue response. J Clin Periodontol 2008; 35(7):649-57.

19. Norton MR. A short term clinical evaluation of immediately restored maxillary TiOblast single tooth implants. Int J Oral Maxillofac Implants 2004; 19:274-281.

20. Kan JY, Rungcharassaeng K, Lozada J. Immediate placement and provisionalization of maxillary anterior single implants: 1-year prospective study. Int J Oral Maxillofac Implants 2003;18(1):31-9.

21. Turkyilmaz I, Avci M, Kuran S, Ozbek EN.A 4- year prospective clinical and radiological study of maxillary dental implants supporting single-tooth crowns using early and delayed loading protocols. Clin Implant Dent Relat Res 2007; 9(4):222-7.

22. Weber HP, Buser D, Donath K, et al. Comparison of healed tissues adjacent to submerged and non-submerged unloaded titanium dental implants. A histometric study in beagle dogs. Clin Oral Implants Res 1996;7(1):11-9

Choudhary et al

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Wilcko et al

Objective: The purpose of this study was to assess the prevalence of Fluorosis in vil-lages of North Gujarat and comparing it with previous studies to know the effects of miti-gation measures taken to curb Fluorosis.

Methods: A population based survey was done in hundred families of ten villages in North Guja-rat which were selected through purposive ran-dom sampling. These were the same families which were studied in IWMI’s Study (2004) by the team headed by Dr. Rajnarayan Indu and Dr. Tushaar Shah. The fluoride levels of these vil-lages were taken from IWMI’s Study (2004). The clinical grading of Dental Fluorosis in these people was done based on Dean’s Index criteria.

Results: The overall prevalence of Dental Fluo-rosis was 74.1 % among 282 people examined. The prevalence rate of Musculoskeletal Fluoro-sis was 30.2%. Majority of the people were of the view that there was no relief in Joint and Back pain even after using Dharoi water which was introduced for the villages of North Guja-rat as the most sought after initiative to pro-vide good quality water with less Fluoride.

Conclusion: The Fluorosis is still a major public health problem in these villages of North Gujarat. There seems to be quiet insignificant improvement in the Fluorosis condition in these families. The mitigation measure taken to curb Fluorosis like Dharoi water supply seems to be inefficient due to irregular and dirty supply of the water supple-mented by the non-usage of Dharoi water due to certain misconceptions as cited by the people.

Clinical Assessment of Fluorosis and the Effects of Mitigation Measures in Endemic Areas

of Mehsana, Gujarat, India

Ashish Sharma, BDS, PGDPHM1 • P.S. Ganguly, MD2 • Anjali Kothari, MDS3

1. Lecturer, Department of Public Health Dentistry, AMC Dental College & Hospital, Khokhara, Ahmedabad

2. Associate Professor, Indian Institute of Public Health Gandhinagar- IIPHG

3. Professor and Head of Department of Conservative Dentistry and Endodontics, AMC Dental College, Ahmedabad

Abstract

KEY WORDS: Dean’s Index, Dharoi water supply, Fluoride, Musculoskeletal Fluorosis, Dental Fluorosis

The Journal of Implant & Advanced Clinical Dentistry • 49

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50 • Vol. 5, No. 7 • July 2013

INTRODUCTIONFluorosis is water borne Non Communicable disease. Fluorosis is a disease caused due to excessive ingestion of fluoride in human or ani-mal body.1 Endemic fluorosis remains a chal-lenging and extensively studied national health problem in India. It is estimated that 25 to 30 million Indians are exposed to the risk of fluoro-sis in various endemic regions and half a million are crippled by it.2 Hence, fluorosis has become a major public health problem in India. The groundwater of 4,341 or 52.6% villages of the total 8,252 villages in Gujarat, India is contami-nated with more than 1.5 mg/litres of fluoride.3 The villages of North Gujarat which were chosen for this study are already endemic for fluorosis.

Fluorosis is a crippling disorder due to entry of fluoride in the body. The incubation period of Fluorosis is very long. Many symptoms of Fluoro-sis are somewhat alike with other diseases such as arthritis and osteoporosis.3 Skeletal Fluoro-sis, which may be related to too much Fluoride in the ground water, has been shown to cause health issues such as pain in joints and back, inability to bow the arms and knees, heel pain, painful and restricted joint movements, deformi-ties in limbs, hunch back, and immobility which may lead to paralysis.8 Dental Fluorosis is a convenient biomarker of exposure to fluoride.4

To a certain extent, as per the World Health Organization (WHO), 0.6 ppm fluoride ingestion is useful for bone and teeth development, but exces-sive ingestion causes Fluorosis. WHO and BIS: 10500-1991 standards permit only 1.5 mg/l and 1.0 mg/l as a safe limit for human consumption.9

The aim of our study was to do a trend analysis of Fluorosis in North Gujarat and to assess the prevalence and severity of dental

and skeletal Fluorosis in the endemic areas of North Gujarat, India. Additionally, we sought to assess the impact of Fluorosis mitigation measures like water supply from Dharoi dam, in endemic areas of North Gujarat by mak-ing a primarily qualitative comparison of indi-vidual physical symptoms between pre and post implementation (of mitigation measures) phase.

MATERIALS AND METHODSThe villages of North Gujarat endemic for fluo-rosis have been selected for this survey to have more accurate and deeper insight into the gravity of the Fluorosis problem. This was a population based survey study design with duration of April 1 to June 30, 2012 in the vil-lages of Mehsana and Patan districts, India. The population sample Survey was done using a short semi-structured questionnaire.

Considering the limited time available for this study, the 10 villages were selected out of the same 25 villages, which were surveyed by the team headed by Dr. Rajnarayan Indu and Dr. Tush-aar Shah in 2004. This project was surveyed as IWMI’s Study in 2004 under the name of Fluo-rosis in Gujarat: A Disaster Ahead.3 The pres-ent prevalence rate of Fluorosis was determined in the 10 villages for the seven years space, by taking a population based census survey using a short questionnaire. This census survey was done by taking following steps: 1) The detailed information was collected from 100 households in 10 out of the 25 census villages of North Gujarat through a structured questionnaire; 2) Each one of 25 villages were arranged accord-ing to Average Fluoride levels in ppm of IWMI’s Study (2004) in a descending order; 3) Out of this information, six villages were selected hav-

Sharma et al

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The Journal of Implant & Advanced Clinical Dentistry • 51

ing Fluoride levels above 4 ppm and four vil-lages were selected having Fluoride levels below 2 ppm in a randomized manner for the effec-tive comparison of the Fluorosis afflicted per-sons using water having more and less fluoride levels; 4) Once the villages were selected, the same families who were surveyed in 2004 were listed; 5) These families were stratified and ten were finally selected randomly for the study.

The six very visible symptoms of Fluo-rosis were inquired in the census question-naire: Besides person-wise family details the following information was collected like whether a person is affected by any of the following symp-toms related to Fluorosis: 1) Dental Fluorosis; 2) Can touch chest with chin; 3) Can bend for-ward easily; 4) Can do sit-ups; 5) Can touch back of the head with hands; 6) Crippled.

A person is called “afflicted” with Fluorosis or MSD, when one gives a negative reply to at least one of the 2 to 6 symptoms.3,5 The preva-lence rate of Fluorosis or MSD in the 10 villages was determined by dividing the total number of afflicted persons over the total number of per-sons in percentage. This is a very simple estimate,

since other clinical symptoms related to Fluoro-sis were not considered and no urine and blood samples were taken for fluoride examination.

Before starting the study, ethical clearance was obtained from the Ethical Committee of Indian Institute of Public Health, Gandhinagar, India. Verbal with written consent was obtained from the respondents of the families before com-mencement of the study as there were no inva-sive procedures or drug intervention in the study. The identities of the respondents were kept confidential during the study period and also during analysis and after publication of study.

RESULTSIn 100 families having 473 family members, 282 persons were examined clinically for Den-tal fluorosis. The prevalence of Dental fluorosis was 74.1 % among 282 people examined. Out of 282 persons, According to DEAN’s Fluoro-sis criteria,5 Mild fluorosis was present in 125 persons, Moderate fluorosis in 72 persons, Severe fluorosis in 12 persons, Fluorosis Absent in 36 persons and 37 people were not identi-fied because they were edentulous or partially

Table 1: Dental Fluorosis Findings

Dental Fluorosis No. of Persons % of persons

Mild Fluorosis 125 44.3

Moderate Fluorosis 72 25.5

Severe Fluorosis 12 4.3

Absent 36 12.8

NA 37 13.1

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52 • Vol. 5, No. 7 • July 2013

Sharma et al

edentulous as shown in Table 1. Mild Fluoro-sis is maximum in persons between 8 to 29 age groups which show that Fluoride is still entering in their body. Moderate fluorosis is maximum in people between 52 to 62 age groups because the persons of this particular age group would have consumed more fluoride during their chil-dren and adolescent phase as shown in Table 2.

Musculoskeletal Fluorosis/DisordersThe 5 symptoms which have been taken for this survey are the basic physical symptoms of Fluorosis to be checked initially for diagnosing Fluorosis.3,5 In 100 families out of 473 fam-ily members, there were 143 patients suffering from at least one of the five symptoms of Fluo-rosis. It means that more than one person in a family is victim of Fluorosis. The prevalence rate of Musculoskeletal Fluorosis was 30.2%. Out of this 19.6% or 28 persons could not walk

properly. Fifty eight percent of people could not bend forward easily and 67.8% could not sit up properly as shown in Table 3. Out of 143 patients, only 53% or 76 persons took medical treatment as the rest either could not afford or did not believe in medication to cure their pain.

Comparative Analysis with 2004 IWMI Study3

According to the 2004 IWMI study,3 out of total population of 28,425, there were 4,590 patients suffering from at least one of the five symptoms of Fluorosis. The prevalence rate of Musculo-skeletal Fluorosis was 16.1%. Among 4,590 affected persons, 14% or 643 could not even walk properly and more than 64% per cent could not sit-up and bend forward properly in Gujarat. They cannot move without some personal help or without hand-stick. Others, whose severity was found less could manage their daily chore with

Table 2: Grades of DF in Different Age Groups

Age Persons Persons Mild Moderate Severe Group in Examined having DF DF DF Absent NA Yrs. % (n) DF % (n) % (n) % (n) % (n) % (n) % (n)

<8 1.8 (5) 0 (0) 0 (0) 0 (0) 0 (0) 1.8 (5) 0 (0)

8-18 15.2 (43) 79.1 (34) 8.2 (23) 3.5 (10) 0.4 (1) 3.2 (9) 0 (0)

19-29 14.5 (41) 80.5 (33) 8.5 (24) 2.8 (8) 0.4 (1) 2.8 (8) 0 (0)

30-40 13.5 (38) 86.8 (33) 7.1 (20) 4.3 (12) 0.4 (1) 1.8 (5) 0 (0)

41-51 14.2 (40) 87.5 (35) 66.7 (19) 5 (14) 0.7 (2) 0.4 (1) 1.4 (4)

52-62 20 (56) 80.4 (45) 6.7 (19) 7.4 (21) 1.8 (5) 1.8 (5) 2.1 (6)

>62 21 (59) 49.2 (29) 7.1 (20) 2.5 (7) 0.7 (2) 1.1 (3) 9.6 (27)

Sharma et al

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lot of pains, complained all most all of them. It’s really a painful scenario in the villages! Only 4% of the total population and about 23% of the afflicted persons took medical treatment; rest 77% either could not afford or did not believe in medication to cure their pain. Out of these 28,425 people nearly 36% or 10,126 persons were also suffering from Dental Fluorosis (DF).

According to the present research study, the prevalence rate of Musculoskeletal fluoro-sis is 30.2%. By taking into consideration the fact in this study that only 473 persons of the 100 families have been checked for the symp-toms of musculoskeletal fluorosis as compared to 28,425 persons in IWMI study, it can be concluded that the prevalence rate of musculo-skeletal fluorosis (30.2% in present study and 16.1% in IWMI study) is still higher and there is negligible effect of Dharoi water supply or other preventive measures in curbing the fluo-rosis in these villages of North Gujarat. Simi-larly the prevalence of Dental Fluorosis in this study is 74.1% amongst 282 people examined as compared to IWMI study where the preva-lence was 30.2% amongst 28425 persons

examined. In IWMI study the Dean’s Index crite-ria was not used and the various cases of mild fluorosis were not taken into account. This can be further explained by the fact that the person having non discolored tooth can also be diag-nosed as Mild Dental fluorotic case accord-ing to Dean’s index criteria. In this study the Mild Fluorosis was present in maximum num-ber of persons that is almost 44.3% which is quite significant. “Dean advised that when the average child in a community has mild Fluoro-sis, “. . . it begins to constitute a public health problem warranting increasing consideration”1.

Thus it can be concluded that the Flu-orosis is still a major public health prob-lem in these villages of North Gujarat.

Perception of pain with duration of Dharoi water supplyOut of 100 families majority of the families were of the view that there is no relief in pain at all after using Dharoi water as shown in following tables. The duration of Dharoi water supply is not regular and on top of it majority of families are using only 50% of Dharoi water for drinking

1 Dean 1942, p. 29).” NRC 2006 p 106

Table 3: Variation of Symptoms of MSD in Afflicted Persons

Percent of Can’t Afflicted Total Can’t Can’t Touch Symptoms of Persons of Afflicted Bend Sit-ups Touch Back of Unable Musculoskeletal 473 Family Persons Forward not Chin with Head by to walk Fluorosis Members (143) Easily Possible Chest Hands or move

No. of persons 473 143 83 97 103 59 28

% of symptoms 30.2 100.0 58.0 67.8 72.0 41.3 19.6

The Journal of Implant & Advanced Clinical Dentistry • 53

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54 • Vol. 5, No. 7 • July 2013

Any One

Symptom

of Va/ Cannot Cannot

Total Fluorosis/ Touch Cannot Cannot Touch

No. of MSD Chest Bend do Back of Crippled/ Taking

People Present with Forward Sit- the Head Unable Medical

Examined (Afflicted) Chin Easily Ups with Hand to Walk Treatment

(%) (%) (%) (%) (%) (%) (%) (%)

IWMI 28,425 4,590 992 2,956 2,979 1,515 643 1,046 Study (100) (16.1) (3.5) (10.4) (10.5) (5.3) (2.3) (3.7)

Present 473 143 103 83 97 59 28 76 Study (100) (30.2) (21.8) (17.5) (20.5) (12.5) (5.9) (16)

Table 4: Comparison of Present Study to 2004 IWMI Study

and cooking purposes. The people also have cer-tain misconceptions about non usage of Dharoi water. All these factors support the above men-tioned fact of non relief in the joint and back pain.

RECOMMENDATIONS The high fluoride content in water is the main reason for the Fluorosis in these villages. Hence it requires synergistic action from health plan-ners, health administrators, engineers and water supply authorities to supply safe drink-ing water with permissible limit of fluoride. The people of these villages are mostly using bore well water for drinking, which adds to the existing problem as it depletes the ground-water leading to excavate further deep for the bore well water. It is known that the content of fluoride in groundwater is directly propor-tional with the depth of water table. Hence,

use of groundwater for drinking should be dis-couraged and be replaced by surface water.Water supply from Dharoi dam being a safer source of surface water with permissible lim-its of fluoride was introduced in these villages as one of the mitigation measure to curb Fluo-rosis. In hundred families studied, around 60% of families receive Dharoi water and 40% of families still don’t receive Dharoi. Incidentally those who are receiving still don’t have regu-lar supply. There are also other problems for irregular supply like pipeline leakage or lack of pressure or hefty bill payments to get Dha-roi water. There were certain misconceptions linked to the non utilization of Dharoi water like water is very cold and filthy and dirty. Some families said that it causes cough and has foul odor and taste. All these factors potentiate the inadequate utilization of Dharoi water. There is

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The Journal of Implant & Advanced Clinical Dentistry • 55

also the habit of mixing Dharoi water with bore well water in order to meet the daily demands of these families which should be discouraged.

Hence all these problems regarding irregu-lar and dirty supply of Dharoi water should be sorted out urgently. The efforts should be made to provide safe and qualitative and regu-lar supply of Dharoi water. The Fluorosis may be related to the other factors like Diet etc. as mentioned in studies and papers like Fluoride and Fluorosis and Reversal of Fluorosis in chil-dren etc. The further research is needed in this regard to understand the role of Diet and Nutri-tion in the prevention and treatment of Fluorosis.

CONCLUSIONThis study concludes that there is still very grim condition of Fluorosis in these ten villages of North Gujarat. The Fluorosis is very much preva-lent in these areas. There seems to be insig-nificant improvement in the Fluorosis condition

in these families. The mitigation measure taken to curb Fluorosis like water supply from Dha-roi dam seems to be inefficient due to irregu-lar and dirty supply of the water supplemented by the non usage of Dharoi water by the people due to misconceptions attached to it as men-tioned above. There seems to be other factors also involved rather than water alone, in caus-ing Fluorosis. Diet can be a major such factor.

One of the MDG that is MDG number seven (Ensure environmental sustainability)2 in context to India is ”the proportion of popula-tion without sustainable access to safe drink-ing water and sanitation is to be halved by 2015” but it seems to be a distant dream especially in these villages of North Gujarat. ●

2 http://www.un.org/millenniumgoals/envi-ron.shtml

Sharma et al

Acknowledgement:We sincerely thank, Dr. P.S. Ganguly Associate Pro-fessor IIPHG, for his guidance, help and motivation to do this study. We would like to express sincere gratitude to Dr. Rajnarayan Indu and Dr. Sunder-rajan Krishnan, the Director of INREM foundation (Carewater) for much help with the research design and methodology and we gratefully acknowledge the financial support from the INREM foundation (Carewater) organization for this study.

Disclosure:The authors report no conflicts of interest with anything mentioned in this article. All information presented in this article was provided by the authors and has not been confirmed by JIACD. This article does not reflect the views or opinions of JIACD.

References:1. Poul Erik Petersen. The global burden of oral

diseases and risks to oral health. Bulletin of WHO September 2005 83(9). http://www.who.int/bulletin/volumes/83/9/661.pdf

2. Dr. Raja Reddy. Alleviation of Endemic Skeletal Fluorosis - GIRISHAVANCHA VILLAGE. http://www.fluorosisinandhra.org/

3. Tushaar Shah and RajnarayanIndu. FLUOROSIS in GUJARAT: A Disaster Ahead. IWMI study 2004 http://www.carewater.org/fluorosisNG.pdf

4. Gopalakrishnan P, Vasan RS, Sarma PS, Nair KS, Thankappan KR.Prevalence of dental fluo-rosis and associated risk factors in Alappuzha district, Kerala. Natl Med J India. 1999 May-Jun; 12(3):99-103. http://www.ncbi.nlm.nih.gov/pubmed/10492580.

5. Dr. Susheela, A K. A Treatise on Fluoride ; 2001

6. FLUORIDE AND FLUOROSIS: fluoride contain-ing items. Fluorosis Research & Rural Develop-ment Foundation (FR&RDF):TheOrganization http://www.fluorideandfluorosis.com/FluorideIt-ems/Contaminated_items1.html

7. Gupta SK, Gupta RC, Seth AK, Gupta A. Reversal of fluorosis in children. Acta Paediatrica Japonica ; Overseas edition 1996 Oct;38(5):513-9.. http://www.ncbi.nlm.nih.gov/pubmed/8942013

8. http://www.helphospital.org/joomla/news/122-kakoo-bai-has-also-fluorosis. PGT SocialWeb - Copyright © 2010 by pagit.eu Kakoo Bai has also Fluorosis! Sri Swami Madhavanada Austria Hospital

9. INDIAN STANDARD DRINKING WATER - SPECIFICATION ( BIS 10500 : 1991 ) http://inprom-file.s3.amazonaws.com/837_ard_drink-ing_water_quality.pdf

Correspondence:Dr. Ashish [email protected]: 9898604936

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