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This manual is aimed exclusively at clinical professionals and is not a substitute for guided surgery courses. The manual, including all images and logos, is protected by copyright. Any use which violates copyright law is prohibited and punishable unless authorized in writing by Cortex Dental.

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i n d e x

Procedure & System Introduction 3

Fully Guided Surgery Kit Layout 4 - 5

Implant Site Preparation Diagram 6

Description of Guided Surgery Kit Tools & Drills 7 - 9

Recommended General Drilling Protocol 10 - 11

Basic Drilling Technique Guidelines 12

Clinical Procedure Description 13 - 18

Virtual Case Planning Work-flow 19

Radiological Protocol 20 - 21

Virtual Case Planning Description 22 - 23

General Work-flow 24

Production Of Custom Made Components 25

Stone Model Analog Manufacturing 26 - 27

Cortex Fully Digital System 28

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Pre-Implant Prosthetic Planning

Virtual Planning Surgical Phase

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P r o c e d u r e & S y s t e m I n t r o d u c t i o n

Cortex guided surgery procedure is a technique of guided surgery based on the following principles:

• Accurate three-dimensional information of the patient’s anatomy exported from theCBCTscan(DICOMfiles)andopticalscanningofaplastermodeloran intraoralscan(STLfiles),uploadedintoavirtualplanningsoftware.

• Utilizingcertifiedandvalidatedsoftwareprogramsallowsthecliniciantodevelop a complete and precise pre-implant diagnosis, and creates a custom virtual surgica plan.

• The latest CAD/CAM technology is used to prepare a virtual wax-up of the prosthetic solution, allowing to create a prosthetic driven virtual implant planning, as well as surgical guide design and manufacturing.

• Management of any type of implant rehabilitation intervention.

• Open system and completely applicable to Cortex implant platforms, and fully

• integrated with open software`s for virtual design with laboratory prosthetic modeling of provisional solutions. Starting with implant planning up to immediate loading, that is supplied in prior to surgery day.

• Fully guided surgical procedure, from virtual implant planning to clinical execution, by using the surgical guide and an advanced Cortex Guided Surgery Kit.

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F u l l y G u i d e d S u r g e r y K i t L a y o u t

CK-GS11

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F u l l y G u i d e d S u r g e r y K i t L a y o u t

Torque Ratchet 15-100 [N

cm]

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Tissue PunchCD-GSTP

Depth Drill� 2,0 X 8,0 mm

CD-GS0822

Calibrated Drill� 2.8 x 8,0 mm

CD-GS0828

Calibrated Drill� 3,4 x 11,5 mm

CD-GS1134Guided Bone Mill

CD-GSTCH

Start DrillCD-GS1001

Depth Drill� 2,0 x 11,5 mm

CD-GS1122

Calibrated Drill� 3,4 x 8,0 mm

CD-GS0834

I m p l a n t S i t e P r e p a r a t i o n D i a g r a m

Preparation DiagramThe preparation diagram of the implant site is shown below as an example for an implant of ø 3.8x11.5 mm. Refer to the table on pages 10-11 and the description of the various steps of the surgical procedure according to the following. instructions.

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Start Drill The start drill removes the mucosa cut by themucotomy and prepares the cortical bone for thepassage of the following drills.

Fixation Pins Drill Thefixationpindrillcutsatthetip. The drill should pass completely through the sleeve toguaranteeaproperfixation.

CD-GSFP CD-GS1001

Fixation Pin Thefixationpinfixesthesurgicalguideintoposition. The pin must be pushed all the way through the sleeve.

CT-GSFP

Drill Stops Drill stops are available at height of 2.0 mm. Theyare completely mountable on all drills to provide a reductionof perforation depth if necessary. This allows Cortex 6 mmimplants to be placed fully guided by simply mounting them on 8 mm depth drills up to the stopper.

CD-GSST52

GS Tissue Punch This tool creates a 4.4 mm diameter mucotomy prior to thepassageofdrillswhenutilizingaflaplesssurgicaltechnique.Incaseswherethereisadeficiencyintheamount of properly keratinized gingival tissue, the mucotome is not recommended.

CD-GSTP

Depth Drills Thedepthdrillsguaranteetheinitialpreparation(2.0mmdiameter) of the implant site for implants that are 8 - 10 - 11.5 - 13 - 16 mm length. To prepare a proper osteotomy depth for implants 6 mm length, mount the 2 mm drill stop on 8 mm depth drills up to the stopper.

CD-GS0822- CD-GS1022 - CD-GS1122- CD-GS1322- CD-GS1622

D e s c r i p t i o n o f G u i d e d s u r g e r y k i t T o o l s & D r i l l s

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Extension for Ratchet Connecting between the torqueratchet and the implant mount.Max torque 60Ncm.

CT-GS440

Short Extension For Ratchet Connecting between the torque ratchet and the implant mount.Max torque 60Ncm.

CT-GSS440

Motor Adaptor Connector for guiding the implant mount with surgical handpiece. Max torque 60Ncm.

CT-GS400

Manual 1.25mm Screwdriver Manual screwdriver to tighten the screw of the implant mount and other screws Hex.

CT-0220

HandPiece 1.25 L10mm Screwdriver to tighten the screw of the implant mount and other screws Hex. 1.25mm with connection to the handpiece or to driver adapter.

CT-D110

Torque Ratchet For manual insertion of implant using the torque ratchet, set torque between 15 and 100 Ncm and verify value .

CT-0863

Implant Mount The implant mount connects to the implant by means ofthe clamping screw and provides a proper direction and depth of the implant through the surgical guide. The hex orientation of the implant mount has a correlation to hex orientation of the implant. Max torque 60Ncm

CO-GS5090(INTHEXPLATFORM),MPR-GS5090 (REGULARCONICALPLATFORM),MPN-GS5090 (NARROWCONICALPLATFORM)

Tapered Drills The tapered drills complete the implant site preparation, whicharedefinedaccordingtothelengthoftheimplant and bone density. As in the case of depth drills, it is mandatorytofirst,usethe8.0mmdrill,thenthedrillcorresponding to the length of the implant to be inserted, up to 13 mm, inserting the 11.5 mm drill for implants 16 mm.

CD-GS0828, CD-GS1028, CD-GS1128, CD-GS1328, CD-GS1628, CD-GS0834, CD-GS1034, CD-GS1134, CD-GS1334, CD-GS1634, CD-GS0837, CD-GS1037, CD-GS1137, CD-GS1337, CD-GS1637, CD-GS0841, CD-GS1041, CD-GS1141, CD-GS1341, CD-GS1641

D e s c r i p t i o n o f G u i d e d s u r g e r y k i t T o o l s & D r i l l s

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Square GS Extractor for Implant Mount Inacaseofthedifficultytoreleasetheimplantmountfromtheimplant(makesurethedifficultyisnotrelatedtothetensionbetweenthesleeveandtheimplantmount).Use this tool according to the next instructions:1. Unscrew the implant mount screw and take it out.2. Screw the extractor into the implant mount in order to release the implant mountfromtheimplant.(Donotapplytorquemorethan15Ncm).

CT-GS262

Guide Screws for Bone Mill Implant connection safety screws and bone mill guide to be inserted AFTER removing the surgical guide.

CO-GS7000(INTHEXPLATFORM),MPR-GS7000(REGULARCONICALPLATFORM),MPN-GS7000(NARROWCONICALPLATFORM)

Tapered Bone Mill Used to remove the residual crestal bone to make site preparation for the abutments. To be used AFTER removing the surgical guide.

CD-GSTCH(INTHEXPLATFORM),CD-GSTCC(CONICALPLATFORM)

Square AdaptorUse driver adaptor for square ratchet & handpiece drivers.

CT-0232

Handpiece Implant Driver L15mm for Conical Narrow Platform

MCT-N215

HandPiece Implant Driver L15mm for Conical Regular platform

MCT-R215

Handpiece Implant Driver L15mm for Internal Hex Platform

CT-H215

D e s c r i p t i o n o f G u i d e d s u r g e r y k i t T o o l s & D r i l l s

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CORTEX FULLY GUIDED SURGERY KIT DRILL SEQUENCE

IMPLANTS STOPPER 2mm

SLEEVECO-GSSL3

Mucotome [800 rpm]CD-GSTP

START DRILL (800rpm)CD-GS1001

Depth drills Ø2.0 [800 rpm] Preparation drills Ø2.8 [800 rpm]

CODE CODE

Implant diameter

[mm]Length [mm]

Code CD-

GSST52Code

ONLY FOR FLAPLESS SURGERY

CD-GS0822 CD-GS1022 CD-GS1122 CD-GS1322 CD-GS1622 CD-GS0828 CD-GS1028 CD-GS1128 CD-GS1328 CD-GS1628

Ø2.0 X 8 Ø2.0 X 10 Ø2.0 X 11.5 Ø2.0 X 13 Ø2.0 X 16 Ø2.8 X 8 Ø2.8 X 10 Ø2.8 X 11.5 Ø2.8 X 13 Ø2.8 X 16

Ø3.0-3.3

6

8

10

11.5

13

16

Ø3.8

6

8

10

11.5

13

16

Ø4.2

6

8

10

11.5

13

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R e c o m m e n d e d G e n e r a l D r i l l i n g P r o t o c o l

NOTE: This Protocol refers to the preparation sequence for D2, D3, D4 bone type. Depending on the scale of Misch. Depending on the bone density (detectableeventhroughthesoftwarefunctions),theDoctormaydecideon thediameterofthefinaldrill,

based on their own clinical experience and depending on the geometry of the implant. Drills Ø4.1 mm can be used only for Hard bone and Implants Ø4.2 up to Doctor decision 800 rpm.

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Preparation drills Ø3.4 [800 rpm] Preparation drills Ø3.7 [800 rpm]Implant Mount

[20rpm-50 Ncm]

IMPLANTSCODE CODE

CD-GS0834 CD-GS1034 CD-GS1134 CD-GS1334 CD-GS1634 CD-GS0837 CD-GS1037 CD-GS1137 CD-GS1337 CD-GS1637Code

Implant diameter

[mm]Length [mm]Ø3.4 X 8 Ø3.4 X 10 Ø3.4 X 11.5 Ø3.4 X 13 Ø3.4 X 16 Ø3.7 X 8 Ø3.7 X 10 Ø3.7 X 11.5 Ø3.7 X 13 Ø3.7 X 16

CO-GS5090 MPN-GS5090 MPR-GS5090

Ø3.0-3.3

6

8

10

11.5

13

16

Ø3.8

6

8

10

11.5

13

16

Ø4.2

6

8

10

11.5

13

16

R e c o m m e n d e d G e n e r a l D r i l l i n g P r o t o c o l

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Keep direction of the handpiece according to insertion axis of the

sleeve. Avoid side levering on the sleeve and surgical template.

Make sure the motor is active (rotating) only when the

drill is fixed inside the guide sleeve. (See picture above).

B a s i c D r i l l i n g T e c h n i q u e G u i d e l i n e s

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The following illustrates the surgical procedure performed with the instruments discussed above. In order to preserve the vitality of the bone, it is important to thoroughly perfuse the surgical area with sterile saline solution at 4°C and 39.2°F.

Positioning of the surgical guidePlacethesurgicalguideandensurestability.Incaseswhichutilizefixationpinstosecureguide, interpose the silicone occlusal bite between the arches and make the patient occlude firmlytoensurethepositionandstabilityofthesurgicalguide.

Pay particular attention during this stage. Placing the guide in the wrong position may effect the entire surgical treatment.

Fixing the surgical guide with fixation pinsInsertthefixationpindrill(CD-GSFP)inthesleeve,pushuntilyoufeelcontactwiththeboneandactivate the motor, pressing on the handpiece up to the limit. Remove the drill and insert the fixationpin(CT-GSFP)immediatelyafterdrilling.Donotproceedtothenextdrillingsitebeforeinsertingthefixationpin.Repeattheprocedureforallthefixationpins.Checkthestabilityoftheguide before proceeding.

Drill at full depth Fixation Pin

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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MucotomyMakeamucotomybyinsertingthededicatedinstrument(CD-GSTP)throughthesleeveof the surgical guide until you feel the mucotome makes contact with the bone crest. The section of soft tissue can be removed through the sleeve with a special detacher or remove the guide to go directly to the gingiva.

Initial PreparationInsertthestartdrill(CD-GS1001)throughtheguidesleevewiththeMOTOROFFuntilthetip touches the bone, check the simultaneous engagement of the cylindrical part of the drillintheguidesleeve,andthenbeginthedrillingphaseatlowspeed(800rpm). Pay particular attention to the insertion of the tip of this drill (perfectly aligned with the guidesleeve)asitdirectstheinsertionofthesubsequentdrills. Verify that the gingiva cut during the mucotomy has been removed completely before drilling the implant site and rinse it thoroughly to prevent the presence of mucosal tissue.

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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Depth PreparationBegintheimplantsitepreparationbyinsertingthe(MANDATORY)first8mmdepthdrill(CD-GS0822)intheguidesleeveof the surgical guide with the MOTOR OFF until the tip touches the bone; check the simultaneous engagement of the cylindricalpartofthedrillintheguidesleeve,andthenbeginthedrillingphaseatlowspeed(800rpm).Dependingonthelength of the implant to be inserted, proceed with the next depth drill according to the following diagram:

• Implantsupto13mminlength:afterusingthe8mmdrill(CD-GS0822),insertthedrillcorrespondingtothe length of the implant to be positioned.

• Implants16mm:afterusingthe8mmdrill(CD-GS0822),insertthe11.5mmdrill(CD-GS1122)andthenthedrill corresponding to the length of the implant to be positioned.

For6mmlengthimplants,mountthedrillstops(CD-GSST52)on8mmdrills.Drilltheboneatfulldrilllengthandatlowspeed(800rpm),thoroughlyperfusingtheimplantsiteaftereachdrillingphasetopreventtheboneoverheating.

Drill ø 2,0 x 8,0 mmCD-GS0822

Drill ø 2,0 x 11,5 mmCD-GS1122

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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Final PreparationContinuepreparingtheimplantsiteusingthepreparationdrills,continuingtousethemaccordinglytothespecificcasesimplantlengthandbonedensity.Asintheprotocolregardingthedepthdrills,itismandatorytofirstusethe8mm drill, then the drill corresponding to the length of the implant to be inserted, up to 13 mm, inserting the 11.5 mm drill for implants that are 16 mm.

Insert the drill in the guide sleeve of the surgical guide with the MOTOR OFF until the insertion of the tip of the drill is felt to be entering the hole made in the bone by the previous drill. Verify the simultaneous engagement of the cylindrical part of the drill into the guide sleeve (DOUBLE GUIDE: of the tip in the previous hole and of the cylindrical bodyintheguidesleeve),andthenstartdrillingatlowspeed(800rpm).

DrillØ 2.8 X 8,0 mm

CD-GS0828

DrillØ 3,4 x 8,0 mm

CD-GS0834

DrillØ 3,4 x 11,5 mm

CD-GS1134

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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Guided Implant PositioningOnce you create the implant site, position the implant using the appropriate implant mount. Place implant mount(checkthatthedriverconnectioniscorrectaccordingtotheimplantusedBEFOREperformingsurgery)ontheimplantandtightentheconnectingscrewwithamanual(CT-0220)orhandpiece(CT-D110)screwdriver(max.15Ncm).Ratchetcanbeusedforholdingimplantmount.

Inserttheimplantallthewaythroughtheguidesleeveusingthesquareconnector(handpiecedriver) (CT-GS400)orthetorqueratchet(CT-0863)(max60Ncm).Incaseofdifficultyinpositioningduetoexcessiveinsertion torque of the implants, remove the implant and prepare with the drill that has a larger diameter or tap with a dedicated tool according to the surgical site. In the case of use of angled abutments, it is important that the hexagon presents in the correct position that corresponds with the plan initiated by the software option and implant mount.

To increase the stability of the surgical guide, keep implant mount in place while proceeding with insertion. In cases with multiple implants it is recommended to inset implants by alternating the right site and left site in order to avoid any possible rotation of the surgical guide, with respect to the center of gravity.

Recommended to maintain max. of 3 implant mount fixed at the same time in the guide in order to avoid excessive stress on the guide and bone. Do not fix two implant mounts in a row.

Note: Aligning hexagons to implant connection

2. Implant- Sleeve- Implant mount.(For 3Diemme and other softwares compatible withthisoption).

Use this tool only for initial implant insertion up to 2mm to final depth. This is to prevent the damage to the prepared bone thread by the implant. (Distance between implant mount Hexagon and theuppersurfaceofthesleeve).

1. Implant- Stent- Implant mount. (For 3Shape and other softwares compatible withthisoption).

2mm Stop

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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Guide removalAt the end of the insertion phase remove the guide in the following order: 1. Fixation pins of the surgical guide. 2. Un-screw and remove all implant mounts one by one.3. Remove the guide.

Adjusting the bone crestVerify the possibility of the correct coupling of the prosthetic components correctly, thereby eliminating any excess soft tissue and residual bone crests that can interfere with the mounting of the abutments.After removing the guide, screw the guide screws to implants by using a hand screwdriver.Place bone mill on the guide screw and start the motor. Perform bone milling until reaching the stopper.

Assembly of prosthesisProceed with the installation of the prosthesis according to standard procedures.

CD-GSTCHCD-GSTCC

CO-GS7000MPR-GS7000MPN-GS7000

C l i n i c a l P r o c e d u r e D e s c r i p t i o n

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V i r t u a l C a s e P l a n n i n g W o r k - f l o w

CT/CBCTExam

OverlappedData

Virtual implant planning

Surgical guide andWork model

With holes for implants analogs modeling

Export in Dicom format

Arch optical scanningAnd diagnostic wax-up

In stl format

LaboratoryProsthetic Modeling

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CBCT protocolBy following 5 basic guidelines for a proper CBCT scan, we can assure optimal radiological and clinical results. A properly accomplished CBCT scan will assist the technician to achieve more accurate results in matching between radiological data and Models STL.

1. Field of view- include the entire jaw (FOV 12x12cm).Atleast250slicesforeachjaw(=250DICOMfiles).

2. Jaws separation- scan the patient with an open mouth. It is possible to use a dental suction tip.

3. Soft tissue separation- separate tongue, cheeks and lips from the jaws.

4. DenturesVerify that any and all removable appliances have been taken out of the patient’smouth.(ForpartialEdentulismonly)InacaseofDoublescantechnique-pleaseprovideadentureCBCT(DICOM),inadditiontopatientsscan with the same denture and 3D markers.

5. Export Full DICOM data files and save in one zipped folder.

R A D I O L O G I C A L P R O T O C O L

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V i r t u a l C a s e P l a n n i n g D e s c r i p t i o n

Overlapping procedure of stl files with the DICOM data setDependingontheSTLdataavailable,overlaptheSTLfileswiththeDICOMdatasetinthe applicable manuals and software according to the following alternative protocols:

Plate guided surgery procedure

Using the 3DMarker as overlapping element of theSTLfileswiththeCT/CBCTexam.

Direct overlapping on the anatomy

Using dental elements as overlapping elements of the model or intra-oral scan with the CT/CBCT exam.

Cbct double scan protocol

Using radio-opaque markers inserted in the patient’s prosthesis duplicate to overlap the DICOM data related to the CT/CBCT of the prosthesis duplicate with the patient’s CT/CBCT exam with the prosthesis in the mouth. In this case, the software will automatically search the reference points in the two dataset and overlap the prosthetic part with the anatomical regions directly.

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V i r t u a l C a s e P l a n n i n g D e s c r i p t i o n

Virtual ModelingThe virtual project of the implants is used for the modeling stage of the surgical guide, the model with the holes correspondent to the implants analogs of the selected implant and the pre-modeling of the provisional prosthesis.

Implant Planning Surgical Guide Provisional wax-up conversion

The result of the procedure therefore consists of all the components needed for minimal invasion and immediate rehabilitation of the patient:

Surgical Guide Model Analog Provisional Prosthesis

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G E N E R A L W O R K F L O W

Surgical guide&Production• Surgical guide• Work model• Provisional prosthesis• Surgical occlusal index

Pre Op Check-UpChecking the Guide inside the Patients mouth beforeSurgery

Guided SurgeryCortex guided surgery surgical kit

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Guiding Sleeve

CO-GSFPSL

CO-GSSL3

P r o d u c t i o n O f C u s t o m M a d e C o m p o n e n t s

Guiding Sleeve for Fixation Drill & Pin

TheresultingSTLfilescanbeusedforproduction,bymeansofrapidprototypingandCAD/CAMtechnologies of all the components required for the transfer of the virtual design in the patient’s mouth, and in particular:

• Construction of the SURGICAL OCCLUSAL INDEX: after mounting the work model and the surgical guide in the articulator, make an occlusal index in silicone with the same rise used for the initial centric occlusion.

• Constructing the PROVISIONAL PROSTHESIS: from the virtual modeling (integrated with the implantsplanning,exportedfromapplicablesoftware),milledwiththeCAD/CAM technology available.

Surgical Guide Model Analog

• Made of biocompatible material (for temporary use, Class I in accordance with Rule 5ofAnnexIX,Directive93/42/EEC).

• Including bio-compatible titanium guide sleeves, dedicated to the CORTEX GUIDED SURGERY.

• Cold sterilisation.

• Completewiththepatient’sname(Optional).

• Model with implant analogs holes, suitable for mounting in the articulator

• Highaccuracyandsurfacefinishing

• Complete with the Patient Name/Code and indication of the size of the implants to be positioned(Optional).

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• A key component to produce a stone model is the Guided cylinder with Pin. Thesetwocomponents(Guidedcylinder(1)andPin(2)ensurethegeometrical relationbetweentheGuidedSleeve(3)andtheImplant.

• MountImplantAnalogs(4)ineachoftheimplantsleevesintheSurgicalStent using the Guided Cylinder with Pin. The analogs and type of Guided Cylinder to use should be chosen according to the implant platform.

• CheckthatthemountedImplantAnalogsfitinthecut-awaysectionofthe stone model.

Guided Cylinder For Model Casting

Guided Pin Screw For Model Casting

MPR-GSCL(REGULARCONICAL),MPN-GSCL(NARROWCONICAL),CO-GSCL(INTHEX).

MPR-GSPS(REGULARCONICAL),MPN-GSPS(NARROWCONICAL),CO-GSPS(INTHEX).

1. Guided cylinder

2. Pin

3. Guided Sleeve

4. Mount Implant Analogs

S t o n e M o d e l A N A L O G m a n u f a c t u r i n g

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* Recommended to use a Duplicate of the Surgical stent.

• Use petroleum jelly to lubricate the bottom of the Guided Cylinder with Pin and the surface of the Surgical Template for easier dismounting of the soft-tissue replica.

• Add soft-tissue analog in the area of the restoration. Use a very small tube to ensure that you can reach right down to the Guided Cylinder with Pin.

• Position the Surgical Template on the Stone Model. Add some sticky wax to secure the proper positioning of the Surgical Template. Verify the proper seating of the Surgical Template via the inspection windows.

• Fill the area to be restored with die stone.

• Verify the proper seating of the Surgical Template via the inspection windows throughout the stone’s setting process.

• Once the plaster has set, unscrew and remove the Guided Cylinder with Pin, the Anchor Pins and the Surgical Template.

• Remove high edges around the template cylinder holes.

S t o n e M o d e l A N A L O G m a n u f a c t u r i n g

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Planning

C o r t e x f u l l y D i g i t a l S y s t e m

Temporization Production Guided Surgery

Highly accurate virtual implant planning.

Top quality and highly accurate 3D printed surgical guide.

Cortex advanced Guided surgery kit. Top quality CAD/CAM prosthetic solutions.

Cortex Digital System – Fully Digital Solution!

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