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Jeder-System:The minimally invasive sinus lift

Articles

A pilot-study of a minimally invasive technique to elevate the sinus floor membrane and place graft for augmentation using high hydraulic pressure: 18-month follow-up of 20 cases. (Jesch P. et al) Oral Surg Oral Med Oral Pathol Oral Radiol 2013; 116:293-300

Minimally invasive sinus floor augmentation based on high hydraulic pressure. A multicenter pilot-study of 20 cases. (Jesch P. et al)JDI Journal of Dental Implantology, 03/2012, p.232-238

Minimally invasive sinus floor augmentation based on high hydraulic pressure. 1-year results of a 20-cases multicenter pilot-study. (Jesch P. et al)Poster, joint congress German/Swiss/Austrian As-sociation of Oral Implantology SGI/DGI/ÖGI 11/2012, Bern, Switzerland

Lectures

Non-invasive sinus lift? Case selection, clinical proce-dure, and prognosis. Annual congress Dental-School (Feb. 2013, Tübingen, Germany)

Minimally-invasive sinus lift using the novel Jeder-System. Bernhard Gottlieb University Clinic of Dentistry, Vienna, (Dec. 2012, Vienna, Austria)

The minimally-invasive sinus lift with the Jeder-System. Wroclaw Medical University(Nov. 2012, Wroclaw, Poland)

Minimally-invasive sinus floor augmentation based on high hydraulic pressure. A multicenter pilot-study of 20 cases. Annual congress German Association of Oral Implantology DGI (Nov. 2011, Dresden, Germany)

ORDERING INFORMATION

Andreas Bayerle

Jeder GmbH. Dental Technology Stadtplatz 14A-3400 Klosterneuburg/Vienna, Austria

T. +43 2243 22597M. +43 664 3913 007F. +43 810 955 411 8233

office@jedersystem.comwww.jedersystem.com

* Watzek, G. The percrestal sinuslift - from illusion to reality. Quintessence Publishing, 2012

JEDER-SYSTEM SHOWING EXCELLENT CLINICAL RESULTSCornerstones clinical study Jeder-System

• Sep. 2010until Feb. 2011

• Clinical investigator Prim.Univ.-Prof. DDr. FranzWatzinger, District ClinicalCenter St. Pölten, Austria

• 2 study-sites in Vienna (medicalpractice Dr. Eder, Dental ClinicWienerberg City)

• 18 patients with 20 sinus liftsincluded in study. Monito-ring done by CoordinationCenter for Clinical Studies(KKS), Medical University,Vienna

• 5% perforation rate of Schneiderian membrane(1 of 20), compared to up to 44% for crestal andup to 60% for lateral sinus lift in literature.*Perforation could only be detected in control-CT,patient was free of symptoms

• Height gain >9 mm (from 4.6 ± 1.4 mm to13.8 ± 2.3 mm)

• Average patient satisfaction of 9.82 on a scalefrom 1 to 10 (1 = „not satisfied“ to 10 = „verysatisfied“)

• On average, 0.17 days of sick leave per patient

• 18-month survival rate of 95% (19 of 20),1 implant was lost 9 months postoperatively

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... cares for your smile

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ManufacturerBIEGLER GmbH | Allhangstrasse 18a | A - 3001 Mauerbach | T. +43 1 979 21 05 | office@biegler.com | www.biegler.com

NOWFDA LISTED

Jeder-System The minimally invasive sinus lift

Abhängig v. Geschick d. Arztes, keine Messung

• No incision/suture, minimal stress for patient• Secure and controlled first entry into sinus by use of hydraulic pressure – no osteotome• Gentle lifting of maxillary sinus membrane• Easy to use, quantifiable results, cost and time effective

Secure first entry into sinus1. Blind hole is drilled up to slightly

below sinus membrane; Jeder-drill is plugged into bore (pressure-tight)

2. Application of hydraulic pressure (1.5 bar) and vibrations using physiologi-cal saline solution (NaCl)

3. Slow movement of centrally placed drill towards membrane

4. Upon first minimal perforation of remaining bone, pressurized fluid pu-shes back membrane, ensuring that drill does not perforate membrane

Gentle lifting of membrane1. Jeder-pump generates hydraulic

vibrations to further raise membra-ne from bone

2. Creation of space for bone replace-ment material

3. Saline solution is extracted and bone replacement material inserted

Monitoring / documentation1. Jeder-pump constantly measures

pressure and volume of inserted fluid (display)

2. Additionally, electronic data recor-ding for documentation

The CE-certified Jeder-System consists of the Jeder-drill, the Jeder-pump and the connecting tube set. The Jeder-drill is the actual surgical tool, the Jeder-pump generates hydraulic pressure and vibrations while

constantly measuring the pressure and volume of the inserted fluid. A surgical procedure using the Jeder-System follows the following steps:

SURGICAL PROCEDURE USING THE JEDER-SYSTEM

ONLY JEDER-SYSTEM FULFILLS ALL 4 CRITERIA FOR “PRACTITIONER-SUITABILITY”Comparison to competing products / technologies

!

31 2

Criteria Minimally invasive

Secure first entry

Gentle membrane

lifting

Quantifiable resultsTechnology /

product

Classic sinus lift (Caldwell-Luc)

Cre

stal

e p

roce

dur

es

Osteotom & Ballon: Sinus Lift Balloon*, BalloonLift Control**

„Intelligent“ drills: Hatch Reamer MISE Set*

Drill & hydraulic pressure: Hydraulic Sinus Condensing Technique***

Jeder-System

Up to 60% perforation rate Results not quantifiable

Results not quantifiable

Results not quantifiable

Constant monitoring of pressure & volume during procedure

Even pressure distribution (Archimed.), “percussion drill”

Direct contact membrane balloon

Non-controllable fracture

Drill cannot lift membrane

High pressure makes membrane “flee” from drill

Depending on skills of dentist, no measurement Results not quantifiable

* Osseous Technologies of America, USA ** Hager & Meisinger, Germany *** Dental Implant Institute of Las Vegas, USASource: Company webpages/flyers, Jeder GmbH analysis

PROCEDURE IS FULLY DOCUMENTED IN A QUANTITATIVE WAY BY JEDER-PUMPCase example: pressure and volume curve

0 10 20 30 40 50 60 70 80 sec.

— volume (ml)

2,00

1,60

1,20

0,80

0,40

0,00

pressure (mmHg)

1500

1000

500

00 10 20 30 40 50 60 70 80 sec.

1. Chart shows pressure inside Jeder-System (blue) and volume of inserted saline solution (red) over time (seconds)

2. Initially, 0.2 ml saline solution is inserted. After 5 seconds, another 0.2 ml is inserted

3. This leads to pressure building up to maximum of ~1,000 mmHg

4. After 15 seconds, clear drop in pressure can be seen (successful first entry into sinus)

5. After this, additional insertion of saline solution only leads to incremental increase in pressure

6. After 65 seconds, solution is extracted leading to negative pressure in the system

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