P ro c e d u r e M a n u a l 2 01 8/2 0 19 - cortex-dental.com · IMPLANT MOUNT The implant mount...

P r o c e d u r e M a n u a l 2 0 1 8 /2 0 1 9

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.

[email protected] www.cortex-dental.com

i n d e x

Procedure & System Introduction

Fully Guided Surgery Kit Layout

Implant Site Preparation Diagram

Description of Guided Surgery Kit Tools & Drills

Recommended General Drilling Protocol

Basic Drilling Technique Guidelines

Clinical Procedure Description

Virtual Case Planning Work-flow

Radiological Protocol

Virtual Case Planning Description

General Work-flow

Production Of Custom Made Components

Stone Model Analog Manufacturing

Cortex Fully Digital System

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4-5

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7-9

10-11

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13-18

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20-21

22-23

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26-27

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PRE-IMPLANT PROSTHETIC PLANNING VIRTUAL PLANNING SURGICAL PHASE

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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.

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

• Accurate three-dimensional reproduction of the patients anatomy integrating data from the CBCT scan and optical scanning of plaster models or an intra-oral scan (STL file).

• Utilizing certified and validated software programs allows the clinician to develop a complete and precise pre-implant diagnosis, and creates a custom virtual surgical plan.• The latest CAD/CAM technology is used to prepare a virtual wax-up of the prosthetic

solution, allowing 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 for virtual design with laboratory prosthetic modeling of provisional solutions. Beginning with implant planning up to immediate loading, we can provide a temporary prosthetic solution.• Fully guided surgical procedure, from virtual implant planning to clinical execution,

by using the surgical guide and an advanced Cortex Guided Surgery Kit.

CORTEX GUIDED SURGERY procedure is a technique of guidedsurgery based on the following principles:

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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

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TISSUE PUNCHCD-GSTP

DEPTH DRILLø 2,0 x 8,0 mm

CD-GS0822

CALIBRATED DRILLø 2.8 x 8,0 mm

CD-GS0828

CALIBRATED DRILLø 3,4 x 11,5 mm

CD-GS1134

START DRILLCD-GS1001

DEPTH DRILLø 2,0 x 11,5 mm

CD-GS1122

CALIBRATED DRILLø 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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FIXATION PINS DRILL

The fixation pins drill cuts at the tip. The drill should pass completely through the sleeve to guarantee that the

pin grips firmly.

CD-GSFP

FIXATION PIN

The fixation pin fixes the surgical guide into position. The pin must be pushed all the way through the sleeve.

CT-GSFP

GS TISSUE PUNCH

This tool creates a 4.4 mm diameter mucotomy prior to the passage of drills when utilizing a flapless

surgical technique. In cases where there is a deficiency in the amount of properly keratinized gingival tissue, the

mucotome is not recommended . Alternatively, prepare the tissue by raising a flap in line with the implant site instead.

CD-GSTP

START DRILL

The start drill removes the mucosa cut by the mucotomy and prepares the cortical bone for the

passage of the first drill. Activate the motor only after start drill is inserted through the guide sleeve.

CD-GS1001

DRILL STOPS

Drill stops are available and are at a height of 2.0 mm. They are completely mountable on all drills to provide a reduction of perforation depth if necessary . This allows Cortex 6 mm implants to be placed fully guided by simply attaching them

to the 8 mm depth drill.

CD-GSST52

DEPTH DRILLS The depth drills guarantee the initial preparation (2.0 mm

diameter) of the implant site for implants that are 8 - 10 - 11.5 - 13 - 16 mm in length. To prepare proper

depth for implants 6 mm in length, insert the 2 mm drill stop to the 8 mm depth drill cylinder.

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 Extension for connection between the torque

wrench and the implant mount.Max torque 60Ncm.

CT-GS440

SHORT EXTENSION FOR RATCHET Extension for connection between the torque wrench and the implant mount.

Max torque 60Ncm.

CT-GSS440

MOTOR ADAPTOR

Connector for guiding the implant mount with surgical hand piece. Max torque 60Ncm.

CT-GS400

MANUAL SCREWDRIVER

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

1.25mm

CT-0220

HAND PIECE SCREW DRIVER 1.25 L10MM

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

connection to the hand piece or to driver adapter.

CT-D110

TORQUE RATCHET

For manual insertion of implant using the torque wrench, set torque between 15 Ncm and 100

Ncm and verify value .

CT-0863

IMPLANT MOUNT

The implant mount connects to the implant by means of the clamping screw, and goes in the direction and to the depth of the implant through the surgical guide. The hex of implant mount also has a reference mark to verify the

implants position through the surgical guide. Max torque 60Ncm.

CO-GS5090 (INT HEX PLATFORM), MPR-GS5090 (REGULAR CONICAL PLATFORM), MPN-GS5090

(NARROW CONICAL PLATFORM)TAPERED DRILLS

The tapered drills complete the implant site preparation, which as to be managed according to the length of the implant and bone density. As in the case of depth drills, it is mandatory to first use the 8.0 mm 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 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


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SQUARE GS EXTRACTOR FOR IMPLANT MOUNT In the event the implant mount is difficult to separate from

implant or becomes lodged, use this tool following these instructions:

1. Unscrew the implant mount screw and take it out.

2. Screw the Extractor into the implant mount in order do release the implant mount from the implant.

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 (INT HEX PLATFORM), MPR-GS7000 (REGULAR CONICAL PLATFORM), MPN-GS7000 (NARROW CONICAL PLATFORM)

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 (INT HEX PLATFORM), CD-GSTCC (CONICAL PLATFORM)

SQUARE ADAPTOR

Use driver adaptor for square ratchet & handpiece drivers.

CT-0232HANDPIECE 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 2.42

CT-H215


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CORTEX FULLY GUIDED SURGERY KIT DRILL SEQUENCE

IMPLANTS STOPPER 2mm

SLEEVECO-GSSL3

Mucotome [800 rpm]CD-GSTP

START DRILL (800 rpm)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

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

NOTE:This Protocol refers to the preparation sequence for D2,D3,D4 bone type. Depending to the scale of Misch .Depending on the bone density (detectable even through the software functions), the Doctor may decide on the diameter of the final drill, 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 hand piece 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 degrees Fahrenheit.

POSITIONING OF THE SURGICAL GUIDEPlace the surgical guide and ensure stability . In cases that utilize fixation pins to secure guide, interpose the silicone occlusal bite between the arches and make the patient occlude firmly to ensure the position and stability of the surgical guide.

PAY PARTICULAR ATTENTION DURING THIS STAGE. PLACING THE GUIDE IN THE WRONG POSITION MAY EFFECT THE ENTIRE SURGICAL TREATMENT.

FIXING THE SURGICAL GUIDEInsert the fixation pin drill (CD-GSFP) in the vestibular sleeve, push until you feel contact with the bone and activate the motor, pressing on the handpiece up to the limit. Remove the drill and insert the fixation pin (CT-GSFP) Insert the fixation pin immediately after drilling. Do not proceed to the next drilling site before inserting the fixation pin. Repeat the operation for all the fixation pins. Check the stability of the guide before proceeding with the other steps.

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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MUCOTOMYRemove the occlusal bite and make a mucotomy by inserting the dedicated instrument (CD-GSTP) through the sleeve of 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 gum, repositioning it at the end of the mucotomy using the silicone bite again.

INITIAL PREPARATIONInsert the start drill (CD-GS1001) through the guide sleeve with the MOTOR OFF until the tip touches the bone, check the simultaneous engagement of the cylindrical part of the drill in the guide sleeve, and then begin the drilling phase at low speed (800 rpm). Pay particular attention to the insertion of the tip of this drill (perfectly aligned with the guide sleeve) as it directs the insertion of the subsequent drills. Verify that the gum cut during the mucotomy has been removed completely before drilling the implant site and rinse it thoroughly to prevent the presence of mucosal tissue.


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DEPTH PREPARATIONBegin the implant site preparation by inserting the (MANDATORY) first 8 mm depth drill (CD-GS0822) in the guide sleeve of the surgical guide with the MOTOR OFF until the tip touches the bone; check the simultaneous engagement of the cylindrical part of the drill in the guide sleeve, and then begin the drilling phase at low speed (800 rpm). Depending on the length of the implant to be inserted, proceed with the next depth drill according to the following diagram:

• Implants up to 13 mm in length: after using the 8 mm drill (CD-GS0822), insert the drill corresponding to the length of the implant to be positioned

• Implants 16 mm: after using the 8 mm drill (CD-GS0822), insert the 11.5 mm drill (CD-GS1122) and then the drill corresponding to the length of the implant to be positioned.

For 6mm length implants, mount the drill stops (CD-GSST52) on 8mm drills. Drill the bone at full drill length and at low speed (800 rpm), thoroughly perfusing the implant site after each drilling phase to prevent the bone overheating.

DRILL ø 2,0 x 8,0 mmCD-GS0822

DRILL ø 2,0 x 11,5 mmCD-GS1122


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FINAL PREPARATIONContinue preparing the implant site using the preparation drills, continuing to use them accordingly to the specific cases implant length and bone density. As in the protocol regarding the depth drills, it is mandatory to first use the 8 mm 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 previous hole and of the cylindrical body in the guide sleeve), and then start drilling at low speed (800 rpm).

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


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GUIDED IMPLANT POSITIONINGOnce you create the implant site, position the implant using the appropriate implant mount. Place implant mount (check that the driver connection is correct according to the implant used BEFORE performing surgery) on the implant and tighten the connecting screw with a manual (CT-0220) or handpiece (CT-D110) screwdriver (max. 15 Ncm). Ratchet can be used for holding implant mount.

Insert the implant all the way through the guide sleeve using the square connector (handpiece-driver) (CT-GS400) or the torque wrench (CT-0863) (max 60 Ncm). In case of difficulty in positioning due to excessive insertion 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 the 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 with this option).

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 the upper surface of the sleeve).

1. Implant- Stent- Implant mount.(For 3Shape and other softwares compatible with this option).

2mm Stop


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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 screw driver.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


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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).At least 250 slices for each jaw (=250 DICOM files).

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

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

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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.

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

4. DenturesVerify that any and all removable appliances have been taken out of the patients mouth. (For partial Edentulism only)• In a case of Double scan technique- please provide a denture CBCT (DICOM), in addition

to patients scan with the same denture and 3D markers.

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 SETDepending on the STL data available, overlap the STL files with the DICOM data set in the applicable manuals and software according to the following alternative protocols:

PLATE GUIDED SURGERY PROCEDURE

DIRECT OVERLAPPINGON THE ANATOMY

CBCT DOUBLE SCAN PROTOCOL

Using the 3DMarker as overlapping element of the STL files with the CT/CBCT exam.

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

Using radio-opaque points 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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IMPLANT PLANNING SURGICAL GUIDE

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

PROVISIONAL WAX-UP CONVERSION

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.

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

• SURGICAL GUIDE• WORK MODEL• PROVISIONAL PROSTHESIS• SURGICAL OCCLUSAL INDEX

CHECKING THEGUIDE INSIDE THE

MOUTH OF THEPATIENT BEFORE

SURGERY

SURGICAL GUIDE&

PRODUCTION PRE OP CHECK-UP GUIDED SURGERY

CORTEX GUIDED SURGERY SURGICAL KIT

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GUIDING SLEEVE FOR FIXATION

DRILL & PIN

GUIDED 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

The resulting STL files can be used for production, by means of rapid prototyping and CAD/CAM technologies 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 modelling (integrated with the implants planning, exported from applicable software), milled with the CAD/CAM technology available.

SURGICAL GUIDE MODEL ANALOG

• Made of biocompatible material (for temporary use, Class I in accordance with Rule 5 of Annex IX, Directive 93/42/EEC).

• Including bio-compatible titanium guide sleeves, dedicated to the CORTEX GUIDED SURGERY.• Cold sterilisation.• Complete with the patient’s name (Optional).

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

• High accuracy and surface finishing• 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. These two components (Guided cylinder(1) and Pin(2)) ensure the geometrical relation between the Guided Sleeve(3) and the Implant.

• Mount Implant Analogs(4) in each of the implant sleeves in the Surgical Stent using the Guided Cylinder with Pin. The analogs and type of Guided Cylinder to use should be chosen according to the implant platform.

• Check that the mounted Implant Analogs fit in the cut-away section of the stone model.

GUIDED CYLINDER FOR MODEL CASTING

GUIDED PIN SCREW FOR MODEL CASTING

MPR-GSCL(REGULAR CONICAL),MPN-GSCL (NARROW CONICAL),

CO-GSCL (INT HEX).

MPR-GSPS(REGULAR CONICAL),MPN-GSPS (NARROW CONICAL) ,

CO-GSPS (INT HEX).

1

2

3

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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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• 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.

* Reccomended to use a Duplicate of the Surgical stent.

• 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.

Advanced Cortex Guided surgery kit. Top quality CAD CAM prosthetic solutions.

CORTEX DIGITAL SYSTEM – FULL DIGITAL SOLUTION!

AC

-SU

RM

AN

GS

(Nov

201

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P ro c e d u r e M a n u a l 2 01 8/2 0 19 - cortex-dental.com · IMPLANT MOUNT The implant mount...

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