a perfect fit CAMLOG GUIDE SYSTEM Planning, template fabrication and implantation

Transcription

1 a perfect fit CAMLOG GUIDE SYSTEM Planning, template fabrication and implantation

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3 TABLE OF CONTENTS GENERAL SYSTEM INFORMATION ON THE CAMLOG IMPLANT SYSTEM CAMLOG GUIDE SYSTEM PRODUCT DESCRIPTION HEALING OPTIONS PRODUCTION OVERVIEW SCREW-LINE IMPLANTS CAMLOG GUIDE, PROMOTE PLUS, AND INSTRUMENTS ADDITIONALLY REQUIRED CAMLOG GUIDE INSTRUMENTS FOR BONE QUALITIES 1 AND 2 CAMLOG GUIDE INSTRUMENTS FOR IMPLANT DIAMETERS 3.8 MM AND 4.3 MM REQUIRED SURGICAL-PROSTHETIC INSTRUMENTS OF THE CAMLOG IMPLANT SYSTEM COMPONENTS FOR THE FABRICATION OF AN IMMEDIATE TEMPORARY RESTORATION APPLICATION IMPRESSION TAKING AND CAST FABRICATION WAX-UP/SET-UP FABRICATION PLANNING TEMPLATE FABRICATION X-RAY DIAGNOSIS AND IMPLANT POSITION PLANNING CONVERTING THE PLANNING TEMPLATE INTO A DRILLING TEMPLATE CHECKING THE DRILLING TEMPLATE WITH IMPLANT3D/CEHA IMPLANT AND THE Q1 CONTROL BOARD OPTIONAL: FABRICATING A TEMPORARY RESTORATION PREPARING THE IMPLANT BED IMPLANTATION TEMPORARY RESTORATION HEALING PHASE FINAL PROSTHETIC RESTORATION FURTHER DOCUMENTATION

4 GENERAL SYSTEM INFORMATION ON THE CAMLOG IMPLANT SYSTEM THE CAMLOG IMPLANT SYSTEM The CAMLOG Implant System is based on many years of clinical and laboratory experience and is a user-friendly, consistently prosthesis-oriented implant system. All CAMLOG products are continually updated to the latest technological standards. The CAMLOG Implant System is being continuously developed and adapted by the CAMLOG research and development team in collaboration with clinics, universities and dental technicians and therefore stays abreast of the latest developments in technology. SCREW-LINE IMPLANTS OF THE K-SERIES FOR THE CAMLOG GUIDE SYSTEM To give CAMLOG Guide System users the option of Platform Switching, the SCREW-LINE implants of the CAMLOG Guide System were changed from J to K article numbers. These implants feature square grooves in the Tube-in-Tube inner configuration. SCREW-LINE implants CAMLOG Guide can still only be combined with all abutments and impression posts with K article numbers (K-Series). Bar, ball and locator abutments are still compatible. The CAMLOG Implant System is very well documented scientifically. Numerous studies addressing a number of parameters, e.g., implant surface, time of implantation and/or implant loading, primary stability, connection design or type of suprastructure, support this. The long-term results for the CAMLOG Implant System are convincing. ATTENTION! The descriptions that follow are not adequate to permit immediate use of the CAMLOG Implant System. Instruction by an experienced operator in the management of the CAMLOG Implant System is strongly recommended. CAMLOG dental implants and abutments should be used only by dentists, physicians, surgeons and dental technicians trained in the system. Appropriate courses and training sessions are regularly offered by CAMLOG. Methodological errors in treatment can result in loss of the implant and significant loss of peri-implant bone. Tube-in-Tube implant abutment connection with square implant grooves and abutment cams Abutment of the K-Series SCREW-LINE implant of the K-Series ATTENTION! Due to the shortened square grooves, SCREW-LINE implants CAMLOG Guide with the K article number (K-Series) cannot be provided with abutments with the J article number (long cams).

5 CAMLOG GUIDE SYSTEM INTRODUCTION PRODUCT DESCRIPTION The components of the CAMLOG Guide Systems Guide System are used for template-guided preparation of the implant bed and for insertion of SCREW-LINE implants CAMLOG Guide, Promote plus, in a partially or fully edentulous maxilla and mandible. The CAMLOG Guide System includes: Dental laboratory instruments for converting a planning template into a drilling template Surgical instruments for template-guided endosseous- or periodontal-supported implant bed preparation and implant insertion SCREW-LINE implants CAMLOG Guide, Promote plus. To use the CAMLOG Guide System, the practice/laboratory must have one of the following 3D planning systems and if necessary, the associated tubing positioning system: implant3d with X1med3D or X2med3D and the Q1 control board (information available at CeHa implant with X1med3D or X2med3D and the Q1 control board (information available at codiagnostix with gonyx (information available at Together with the planning software and the tube positioning system (called «positioner» hereafter), the laboratory instruments of the CAMLOG Guide Systems are used in the dental laboratory to convert an existing planning template into a drilling template. As an alternative to fabricating a drilling template on a positioner, some manufacturers of planning systems offer to manufacture the drilling template in centralized production. Drilling templates with CAMLOG Guide guiding sleeves can be fabricated using the data from the following planning systems: SimPlant ( GALILEOS Implant / SICAT Implant ( When using these systems, the laboratory CAMLOG Guide instruments (control pin, seating instrument and template drill) for fabricating the template are not required. SCREW-LINE implants CAMLOG Guide, Promote plus are available in 3. 8 and 4.3 mm diameters. Single crowns, bridges or full dentures complete the prosthetic restoration. The CAMLOG Guide System is part of an overall treatment concept and should only be used with the implants and instruments described subsequent. All components of the CAMLOG Guide System are precisely matched to one another. Once fabricated, the drilling templates with CAMLOG Guide guiding sleeves are used to: a) Positionlab analogs during preoperative fabrication of the model and long-term temporary restoration b) Guide surgical instruments of the CAMLOG Guide Systems during implant bed preparation c) Guide SCREW-LINE implants CAMLOG Guide during their insertion. NOTE ALTATEC GmbH/CAMLOG Biotechnologies AG assume no liability for executing the planning and its implementation by fabricating the drilling template. The user must have familiarized his/herself with the 3D planning system and positioner used prior to using the CAMLOG Guide System. NOTE SCREW-LINE implants CAMLOG Guide, Promote plus, differ from conventional SCREW-LINE implants, Promote plus in a modified insertion post, only. To implant the SCREW-LINE implants CAMLOG Guide, Promote plus, the associated driver for CAMLOG Guide implants, short, manual/ratchet, diameters 3.8/4.3 mm, Art. No. J , is required. IMPORTANT NOTE! For some planning systems, gingiva-supported drilling templates can be used. However, CAMLOG does not recommend nor describe such templates because correct positioning cannot be ensured due to anatomical conditions. In addition, the resilience of the mucous membrane can cause the position of the drilling templates to shift and lead to inaccuracies in their application. HEALING OPTIONS The healing options of the SCREW-LINE implants CAMLOG Guide, Promote plus are: Subgingival healing with cover screw Transgingival healing with healing cap Transgingival healing with long-term temporary restoration as immediate restoration 4 5

6 PRODUCT OVERVIEW SCREW-LINE IMPLANTS CAMLOG GUIDE, PROMOTE PLUS, AND INSTRUMENTS IMPLANT DIAMETER 3.8 MM IMPLANT DIAMETER 4.3 MM ART. NO ARTICLE ART. NO. ARTICLE K SCREW-LINE implant CAMLOG Guide, Promote plus, K incl. insertion post and cover screw, diameter 3.8 mm, length 9.0 mm SCREW-LINE implant CAMLOG Guide, Promote plus, incl. insertion post and cover screw, diameter 4.3 mm, length 9.0 mm K SCREW-LINE implant CAMLOG Guide, Promote plus, K incl. insertion post and cover screw, diameter 3.8 mm, length 11.0 mm SCREW-LINE implant CAMLOG Guide, Promote plus, incl. insertion post and cover screw, diameter 4.3 mm, length 11.0 mm K SCREW-LINE implant CAMLOG Guide, Promote plus, K incl. insertion post and cover screw, diameter 3.8 mm, length 13.0 mm SCREW-LINE implant CAMLOG Guide, Promote plus, incl. insertion post and cover screw, diameter 4.3 mm, length 13.0 mm J Gingiva punch CAMLOG Guide, sterile, J diameter 3.8 mm Gingiva punch CAMLOG Guide, sterile, diameter 4.3 mm J Surgery Set CAMLOG Guide, SCREW-LINE, internal irrigation, sterile, diameter 3.8 mm, length 9.0 mm, Contents: Pre-drill CAMLOG Guide diameter 3.8 mm, length 6.0 mm and Form drill CAMLOG Guide diameter 3.8 mm, length 9.0 mm J Surgery Set CAMLOG Guide, SCREW-LINE, internal irrigation, sterile, diameter 4.3 mm, length 9.0 mm, Contents: Pre-drill CAMLOG Guide diameter 4.3 mm, length 6.0 mm and Form drill CAMLOG Guide diameter 4.3 mm, length 9.0 mm J Surgery Set CAMLOG Guide, SCREW-LINE, internal irrigation, sterile, diameter 3.8 mm, length 11.0 mm, Contents: Pre-drill CAMLOG Guide diameter 3.8 mm, length 6.0 mm and Form drill CAMLOG Guide diameter 3.8 mm, length 9.0 and 11.0 mm J Surgery Set CAMLOG Guide, SCREW-LINE, internal irrigation, sterile, diameter 4.3 mm, length 11.0 mm, Contents: Pre-drill CAMLOG Guide diameter 4.3 mm, length 6.0 mm and Form drill CAMLOG Guide diameter 4.3 mm, lengths 9.0 and 11.0 mm

7 IMPLANT DIAMETER 3.8 MM IMPLANT DIAMETER 4.3 MM ART. NO. ARTICLE ART. NO. ARTICLE J Surgery Set CAMLOG Guide, SCREW-LINE, internal J CAMLOG Guide Surgery Set, SCREW-LINE, internal irrigation, sterile, diameter 3.8 mm, length 13.0 mm, irrigation, sterile, diameter 4.3 mm, length 13.0 mm, Contents: Pre-drill CAMLOG Guide diameter 3.8 mm, Contents: Pre-drill CAMLOG Guide diameter 4.3 mm, length 6.0 mm and Form drill CAMLOG length 6.0 mm and Form drill CAMLOG Guide Guide diameter 3.8 mm, lengths 9.0, 11.0 and 13.0 mm diameter 4.3 mm, lengths 9.0, 11.0 and 13.0 mm ADDITIONALLY REQUIRED CAMLOG GUIDE INSTRUMENTS FOR BONE QUALITY 1 AND 2* IMPLANT DIAMETER 3.8 MM IMPLANT DIAMETER 4.3 MM ART. NO. ARTICLE ART. NO. ARTICLE J Form drill CAMLOG Guide SCREW-LINE, J Cortical Bone, internal irrigation, sterile, diameter 3.8 mm, length 9.0 mm Form drill CAMLOG Guide SCREW-LINE, Cortical Bone, internal irrigation, sterile, diameter 4.3 mm, length 9.0 mm J Form drill CAMLOG Guide SCREW-LINE, J Cortical Bone, internal irrigation, sterile, diameter 3.8 mm, length 11.0 mm Form drill CAMLOG Guide SCREW-LINE, Cortical Bone, internal irrigation, sterile, diameter 4.3 mm, length 11.0 mm J Form drill CAMLOG Guide SCREW-LINE, J Cortical Bone, internal irrigation, sterile, diameter 3.8 mm, length 13.0 mm Form drill CAMLOG Guide SCREW-LINE, Cortical Bone, internal irrigation, sterile, diameter 4.3 mm, length 13.0 mm * Lekholm & Zarb, 1985 CAMLOG GUIDE LAB INSTRUMENTS FOR IMPLANT DIAMETERS 3.8 MM AND 4.3 MM ART. NO. ARTICLE ART. NO. ARTICLE J Guiding sleeve CAMLOG Guide, J diameter 3.8 mm, 2 units Guiding sleeve CAMLOG Guide, diameter 4.3 mm, 2 units J Seating tool CAMLOG Guide, for diameters 3.8/4.3 mm 6 7

8 CAMLOG GUIDE LAB INSTRUMENTS FOR IMPLANT DIAMETERS 3.8 MM AND 4.3 MM ART. NO. J ARTICLE Checkup pin CAMLOG Guide, for diameters 3.8/4.3 mm (only required when using the implant3d/ceha implant planning system) J Template drill CAMLOG Guide, for diameters 3.8/4.3 mm COMPONENTS FOR THE FABRICATION OF AN IMMEDIATE TEMPORARY RESTORATION (WITHOUT PROSTHETIC) IMPLANT DIAMETER 3.8 MM IMPLANT DIAMETER 4.3 MM ART. NO. ARTICLE ART. NO. ARTICLE K Insertion post CAMLOG Guide for lab analogs, K incl. fixing screw, diameter 3.8 mm, 2 units Insertion post CAMLOG Guide for lab analogs, incl. fixing screw, diameter 4.3 mm, 2 units J Lab analog, diameter 3.8 mm J Lab analog, diameter 4.3 mm REQUIRED SURGICAL-PROSTHETIC INSTRUMENTS OF THE CAMLOG IMPLANT SYSTEM ART. NO. J ARTICLE Torque wrench with continuous torque adjustment until max. 30 Ncm J Screwdriver, hex, extra-short, manual/wrench J Screwdriver, hex, short, manual/wrench J Screwdriver, hex, long, manual/wrench J Drill extension, ISO shaft J Driver for CAMLOG Guide implants, short, manual/wrench, for diameters 3.8/4.3 mm

9 APPLICATION IMPRESSION TAKING AND CAST FABRICATION A. ADEQUATELY PARTIALLY EDENTULOUS ARCH For a partially edentulous arch, the existing teeth of which provide sufficiently stable and repositionable fixation of a planning template, an impression is taken of the oral situation and a master cast fabricated. B. EDENTULOUS OR INADEQUATELY PARTIALLY EDENTULOUS ARCH For an edentulous or inadequately partially edentulous arch, the residual teeth of which do not provide sufficiently stable and/or repositionable fixation of a planning template, «temporary implants» (snap-action mechanism with matrix) are placed in sufficient numbers (3 units minimum in an endentulous arch) to provide exact fixation of the planning template in the mouth, later. The temporary implants must be positioned to achieve the best possible mechanical stability and not to hinder later insertion of the SCREW-LINE implants CAMLOG Guide, Promote plus. The drilling template for the bite registration is inserted into the mouth of the patient over the temporary implants during the CT/DVT scan and intraoperatively «bone-based». In the case of an immediate restoration, the long-term temporary restoration inserted immediately after surgery can also be fixed over the temporary implants. An impression is taken of the oral situation with the impression components belonging to the temporary implants (depending on the temporary implants used) and a master cast fabricated with corresponding analogs. PLANNING TEMPLATE FABRICATION The planning template is functional and preferably made of transparent plastic. In the previously deep-drawn template, the missing teeth are then filled with suitable x-ray opaque plastic (min % barium sulfate content). The teeth filled in this manner must be flush with the gingiva (see graphic) in order to represent the exact gingival height. As an alternative, Materialise offers bone- and gingiva-supported drilling templates. Observe the manufacturer s instructions. WAX-UP/SET-UP FABRICATION A wax-up/set-up of the teeth to be replaced is prepared on the master cast to determine optimal tooth positioning from a prosthetic perspective for later restoration (planning of the prosthetic restoration in the articulator). The wax-up/set-up is also used as a guideline for the planning template to be fabricated that can be converted later into the drilling template. NOTE Further information about fabricating a suitable planning template incl. the correct positioning of the reference objects that may be necessary is available from the manufacturer of the 3D planning system. 8 9

10 X-RAY DIAGNOSIS AND IMPLANT POSITION PLANNING The planning template is placed on the residual teeth and/or on the temporary implants. The implants must exhibit adequate primary stability. The X-ray topography (CT/DVT) is performed with the template accurately and securely attached. The data acquired from the CT or DVT is transferred to the 3D planning software. After planning the implant position in the 3D software, the data for positioning and aligning the guiding sleeves in the drilling template is available. Height of the guiding sleeve 4 mm Distance from the lower end of the guiding sleeve to the implant shoulder = 3.5 mm IMPORTANT NOTES The following safety margins must be maintained: 1.5 mm to the mandibular nerve or inferior alveolar nerve 1.5 mm to an adjacent natural tooth 3.0 mm to an adjacent implant You must determine the implant diameter and length so that sufficient bone (at least 1.0 mm) is present around the implant. THE GEOMETRIES TO BE CONSIDERED IN THE PLANNING SOFTWARE ARE (IF NOT YET IMPLEMENTED BY THE MANUFACTURER OF THE PLANNING SYSTEM): Height of guiding sleeve: Distance from lower margin of sleeve coronal end of implant (implant shoulder): 4,0 mm 3,5 mm These geometries should not be changed. Otherwise, an incorrect drill and implant seat depth different from planning is implemented! Important geometries CONVERTING THE PLANNING TEMPLATE INTO A DRILLING TEMPLATE (ONLY WHEN USING implant3d, CeHa implant AND codiagnostix ) PREPARING THE TEMPLATE AND DEPTH REFERENCING A. WITH implant3d/ceha implant AND X1med3D To convert the planning template into a drilling template, the teeth of the planning template are first ground down. When grinding the teeth, care should be taken that adequate stability of the template is ensured to prevent breakage when further handled at the laboratory and by the surgeon (possible warping of the template). If it becomes obvious in the planning phase that the basal margin of the guiding sleeve is situated in the soft tissue, a gingival flap has to be created or the gingiva must be removed circular around the implant position in a minimum diameter of 6.0 mm. Thus, the intraoperatively correct positioning of the template is assured. This procedure is important if, in a protocol-conform implant insertion depth (implant shoulder lies 0.4 mm supracrestal), the gingival thickness exceeds 4.0 mm. A required opening of the gingiva has to be discussed with the surgeon. IMPORTANT NOTE The operating instructions for the X1med3D or X2med3D tubing positioning systems from Georg Schick Dental GmbH are described in the instruction manual and must be followed exactly! This concerns the following points: Calibration check of the positioner Depth stop setting for embedding the template in plaster Embedding the template in plaster Checking the safety markings Depth stop setting for the seating depth of the guiding sleeve Placing of the guiding sleeves according to drilling plan. After checking the safety marks, the depth stop settings for the depth of the guiding sleeve should be made on the positioner. For that, the CAMLOG Guide seating instrument with a mounted CAMLOG Guide guiding sleeve is inserted into the milling spindle.

11 WARNING! To ensure the exact seating depth of the guiding sleeves, the CAMLOG Guide seating instrument must be loaded with its complete shaft length up to the stop in the milling spindle chuck. Seating instrument with mounted guiding sleeve The correct adjustment of the coordinates can be checked before drilling. The zero plane base with the gonyx verification protocol is used. Please follow the manufacturer s instructions. DRILLING OUT THE TEMPLATE AND INSERTING THE SLEEVES The hole for the guiding sleeve can now be drilled according to the positioner settings specified by the planning software and documented in the drilling plan/print protocol. Template drill Stop surface for chuck. The shaft must be loaded all the way in the chuck! Guiding sleeve shoulder must be supported! Stop surface for chuck. The shaft must be loaded all the way in the chuck! The depth stop of the positioner should be readjusted by mounting the guiding sleeve between the burlings of the test piece (see also positioner instruction manual). The guiding sleeve must lie on the shoulder of the seating instrument. The seating instrument itself must not lie on the test piece. After setting the depth stop, the seating instrument is replaced with the CAMLOG Guide template drill. WARNING! To ensure the exact seating depth of the guiding sleeves, the CAMLOG Guide template drill must be loaded with its complete shaft length up to the stop in the milling spindle chuck. The length of the CAMLOG Guide template drill already matches the length of the seating instrument so that the depth stop does not have to be readjusted on the positioner. Drilling Planning template NOTE To prevent overheating and possibly associated deformation of the drilled hole, we recommend predrilling with a twist drill, max. 5.0 mm diameter. Drilling in plastic should be performed intermittently and under cooling with compressed air! After drilling in the template is complete, the template drill is replaced with the CAMLOG Guide seating instrument. Take care that the seating instrument is loaded up to the stop. The CAMLOG Guide guiding sleeve that matches the implant diameter is placed on the seating instrument. B. WITH codiagnostix AND gonyx Converting the planning template provides excellent results, but it is also possible to create a drilling template, separately. When using plastic teeth containing barium sulfate, the teeth can remain in the template as long as they provide an adequate mounting surface for the guiding sleeves. IMPORTANT NOTE For depth referencing (zero position determination) of the template drill, it must be ensured that the drill is loaded with its complete shaft length up to the stop in the milling spindle chuck and rests on the zero plane of the model with its point and not on its outer cutting edge. Turn the drill if necessary

12 CAUTION! To ensure the correct seat depth of the CAMLOG Guide guiding sleeve, it must be slid on the CAMLOG Guide seating instrument up to the stop. The described process is carried out for each guiding sleeve, separately. When using the gonyx, depth referencing must be redefined based on the manufacturer s specifications before each drilling. Seating instrument with mounted guiding sleeve NOTE Further information about using the respective positioner is available from the manufacturer. Stop surface for chuck. The shaft must be loaded all the way in the chuck! Guiding sleeve shoulder must be supported! CHECKING THE DRILLING TEMPLATE WITH implant3d/ceha implant AND Q1 CONTROL BOARD One of the final proofs (test sheet) generated by the planning software can be used to check the position of the guiding sleeves after finishing the drilling template. The Q1 control board from med3d GmbH is used via the plugin module to align the template with the reference field of the final proof. If the CAMLOG Guide checkup pin is then guided through the guiding sleeves, the tip of the pin must hit near the cross marks within the circle. Inserted checkup pin Guiding sleeve in the template The seating instrument with the mounted guiding sleeve should be lowered to the depth stop of the positioner. The guiding sleeve is to be bonded into the position lowered to the stop or to be embedded into a polymer with plastic (light-curing). IMPORTANT NOTE Before bonding/embedding the guiding sleeve, it must be ensured that the depth stop of the positioner is reached. 100 mm (check!) Reference field Cross marks with circle Final proof (test sheet)

13 IMPORTANT NOTE The safety marks on the template must be used to check the correct position of the plug-in module. To perform a complete check of a template, the safety marks, final proof and medical feasibility must be verified. NOTE Further information about using the control board is available from the manufacturer. OPTIONAL: FABRICATING A TEMPORARY RESTORATION The finished drilling template can be used to craft a long-term temporary restoration in the laboratory for the partially or fully edentulous jaw before the actual implantation is performed. Insertion posts CAMLOG Guide for integrating lab analogs into the working cast are available, separately. RECOMMENDATION To make mounting the lab analogs easier, grind through the cast on the corresponding implant positions to allow suitable material (e.g., plaster, epoxy, etc.) to flow in from below later. Lateral retention in the holes serves as an antirotational mechanism for the introduced material. B. MOUNTING THE LAB ANALOGS Before mounting, the lab analogs are attached to the corresponding insertion posts and the connection gap as well as the groove on the insertion post above must be blocked out with wax. Block out groove with wax Block out connecting gap with wax The lab analogs are inserted into the guiding sleeves of the template paying attention to the vestibular orientation of a groove. The orientation of the groove is identical to the position of the surfaces on the insertion post. Insertion posts CAMLOG Guide for lab analogs, incl. fixing screw, diameter 3.8/4.3 mm Lab analogs diameter 3.8/4.3 mm PREPARATION AND FABRICATION BASED ON AN EDENTU- LOUS JAW WITH PREVIOUSLY FITTED TEMPORARY IMPLANTS: A: DRILLING THE HOLES FOR THE LAB ANALOGS The finished drilling template with the guiding sleeves is placed on the working model or snapped to the analogs of the temporary implants in the model to mark the future implant position through the guiding sleeves. The template is then removed to properly grind the required cavities for placing the lab analogs in consideration of the implant axes in the plaster. The guiding sleeves are then not damaged by rotary instruments. NOTE To transfer the vestibular groove position of the lab analog to the SCREW-LINE implant CAMLOG Guide, make a permanent mark per implant on the top of the template. The mark should be made next to the guiding sleeve at the height of the middle of the vestibularly aligned surface of the CAMLOG Guide insertion post. Vestibular mark Surface Template with insertion post (occlusal view) 12 13

14 IMPORTANT NOTE The shoulders of the insertion posts must lie on the top of the guiding sleeves. Only then is the exact final position reached! To ensure the correct position, sufficient wax is used to mount the insertion posts fitted in the exact position in the template. The drilling template is placed on the working cast or snapped to the analogs of the temporary implants. The lab analogs may not touch the walls of the drilled holes in the cast. The lab analogs are then mounted in the cast and the material (e.g., plaster, epoxy, etc.) preferably flows from the underside of the cast into the hole. After the material has cured, the template is removed from the cast by loosening the mounted insertion posts. Any residual wax on the coronal margin of the lab analogs is removed. C. FABRICATING THE TEMPORARY RESTORATION The long-term temporary restoration can then be fabricated on the working cast using, for example, bar components (passive fit) or the temporary abutment as an esthetic, non-functional bridge structure. To guarantee tension-free seating, a temporary reconstruction must be cemented in the mouth to the bar bases or the temporary abutment (passive fit). For stability reasons, the implants should be splinted together with a temporary restoration. Temporary single tooth restorations can be fabricated on the temporary abutment in the conventional manner. PREPARING THE IMPLANT BED The diagnostic documentation and the previously fabricated, cleaned and disinfected drilling template must be made available for the surgical intervention. The implantation can be performed transgingivally (1-step) or subgingivally (2-step). In the case of a transgingival implantation, a second surgical intervention is unnecessary. In the case of a subgingival implantation procedure with cover screw, a healing cap for soft-tissue conditioning must be screwed into the implant three weeks before the impression taking. IMPORTANT NOTE To create optimal conditions for successful healing of the implants, the hard and soft tissue must be treated gently. The implant bed must be prepared with the utmost care. NOTE An opened gingiva facilitates viewing the operation area. Opening or punching is necessary if the planning shows that a guiding sleeve of the drilling template will be positioned in the soft tissue. For that, see the note in «X-ray diagnosis and implant position planning». INSERTING THE TEMPLATE AND PREPARING THE GINGIVA The cleaned and disinfected drilling template is placed in the mouth and checked for proper seating. In the edentulous or inadequately dentulous jaw, it is mounted to the previously placed temporary implants to ensure a stable seat. If the arch is adequately partially edentulous, it can be supported on the residual teeth. IMPORTANT NOTE If the gingiva is open, the flap should not hinder the correct positioning of the template. Template Gingiva Bone

15 OPTIONAL: GINGIVAL PUNCHING As an alternative to conventional flap preparation of the gingiva, the CAMLOG Guide gingival punch can be inserted into the guiding sleeve and the gingiva pierced and removed at the implant position. 15 rpm should not be exceeded when rotating insertion is used. To prevent connective tissue encapsulation in the implant bed, any remaining gingiva must be removed from the drilling area and the marginal gingiva mobilized, if necessary. Gingiva punch Adequate external/internal cooling from with prechilled (5 C) sterile physiological saline solution is required. The drills are used in ascending lengths. Maximum permitted drill speed: Pre-drill and form drill CAMLOG Guide, diameter 3.8 mm 500 U/min Pre-drill and form drill CAMLOG Guide, diameter 4.3 mm 400 U/min Form drill CAMLOG Guide SCREW-LINE, Cortical Bone, diameter 3.8/4.3 mm 300 U/min PRE-DRILLING An internally irrigated CAMLOG Guide pre-drill is used. The pre-drilled hole clearly defines the drilling and implant axis. Pre-drill Drilling depth: 6.0 mm Max. speed: diameter 3.8 mm: 500 rpm diameter 4.3 mm: 400 rpm Removed gingival plug Cooling required! FORM DRILLING In ascending drill lengths ( mm) after the pre-drilling is complete, the internally irrigated CAMLOG Guide form drills prepare the implant bed up to the planned length of the implant. Form drill length 9 mm PRE-DRILLING AND FORM DRILLING NOTE To prevent wear on the guiding sleeves by the drill bit, only start the drill when it touches the inner surface of the guiding sleeve with its cylindrical guide shaft. The pre-drill and form drill are used with an intermittent drilling technique, i.e., drill bone 2 to 3 seconds, then pull the drill upward from the bone without stopping the motor. Repeat the procedure until the desired depth is obtained

16 Form drill length 11 mm IMPLANTATION The SCREW-LINE implants CAMLOG Guide, Promote plus, incl. cover screw and pre-installed insertion post are delivered sterile and fixed with a handle in the primary package (blister). The primary package of the implant is opened and the implant only removed from the package by the handle. NOTE The primary packaging of the implants contains a label with the lot number, which must be recorded in the patient s documentation. This makes it possible to trace each implant, if needed. Form drill length 13 mm CAUTION! The silicone plug and cover screw must be removed from the handle prior to implant insertion. Holding the implant by the placement head, it is inserted by hand through the guiding sleeve of the drilling template into the implant bed. Screw the implant with the placement head up to its first stabilization and pull off the placement head. Max. speed: diameter 3.8 mm: 500 rpm diameter 4.3 mm: 400 rpm Placement head Pull off the placement head Cooling required! NOTE FORM DRILL CAMLOG GUIDE SCREW-LINE, CORTICAL BONE If implant bed preparation discloses predominantly cortical bone (bone qualities 1 and 2, Lekholm&Zarb, 1985) the CAMLOG Guide, SCREW- LINE, Cortical Bone form drill can be used to widen the apical portion of the implant bed (see «Product Overview»). The maximum speed should not exceed 300 rpm. The result is a reduction in the torque of the implant. Insertion post

17 The CAMLOG Guide driver is inserted up to the stop on the insertion post. The locked torque wrench is then placed on the driver. The implant is then tightened into place in the bone. Longitudinal mark is identical to the orientation of the groove in the implant Final position Locked torque wrench Driver WARNING! The shoulders of the insertion post must lie on the top of the guiding sleeve. Only then is the exact final vertical position reached. After reaching the final position, the implant should not be tightened any further in the template. Doing so can lead to loss of primary stability. After tightening, a longitudinal mark should be vestibularly oriented on the CAMLOG Guide driver (position corresponds to the position of the grooves in the internal configuration of the implant) or when available, point toward a mark on the template made by the dental technician. RECOMMENDATION If a groove in its end position does not point vestibularly or toward the mark made by the dental technician, the implant position can then be corrected slightly only after removing the template. For that, the insertion post and the template must be removed. After that, reinsert and tighten the insertion post, attach the driver incl. torque wrench and correct the groove position

18 Pull the torque wrench and driver off of the insertion post, use the screwdriver to loosen the insertion post retaining screw and extract the insertion post. NOTE For soft bone relationships (e.g. 3 and 4, Lekholm & Zarb 1985), the driver should be used for fixation of the insertion post before loosening the fixing screw with the screwdriver, hex, long, manual/ratchet, Art. No. J The screwdriver is inserted into the fixing screw from the top through the driver. The drilling template is removed and the inner configuration of the implant cleaned. Depending on the situation or planning, the implant will be supplied in the healing phase with a cover screw or a healing cap. The soft tissue is stabilized. A long-term temporary restoration can also be used as needed. A healing cap can be used after gingival punching or opening the gingiva. This makes transgingival healing possible (single-stage). The healing cap must match the implant diameter and the thickness of the gingiva, and is screwed in by hand. Check for an exact seat of the healing cap. In particular, ensure that no tissue is pinched between implant shoulder and healing cap. The mucosa must adapt tightly against the healing cap. When preparing a flap, the wound margins are closed tightly with appropriate suture material. Do not tie the sutures too tightly. They must be placed in such a way that the wound margins lie tension-free over the cover screw.

19 TEMPORARY RESTORATION HEALING PHASE SUPPORT ON TEMPORARY IMPLANTS A temporary restoration may be inserted only after ensuring that no mechanical friction occurs against the implant in its final position and against the suture. The healing phase should last at least 6 weeks in good bone quality and 12 weeks in cancellous bone quality. These times apply to both maxilla and mandible. SUPPORT ON FINAL IMPLANTS (IMMEDIATE LOADING) To guarantee tension- free seating, temporary reconstructions must be cemented in the mouth on the bar bases or the temporary abutments (passive fit). For stability reasons, the implants should always be firmly splinted together with a temporary restoration. RECOMMENDATIONS If the residual teeth are inadequate, support the temporary restoration on the temporary implants. The maximum wearing time of the long-term temporary restoration (temporary abutment, PEEK ) should not exceed 6 months

20 FINAL PROSTHETIC RESTORATION FURTHER DOCUMENTATION The final prosthetic restoration for the implant should be performed only after the soft tissue has healed completely and is not inflamed. Before starting the restoration procedure, radiographs should be taken after 6 12 weeks of healing. Depending on the situation, the final prosthetic restoration is carried out with the diameter-specific prosthetic system components of the CAMLOG Implant System for fixed superstructures such as crown and bridge restorations or hybrid restorations. The impression taking can be made with the open or closed method. Color-coding SCREW-LINE implants CAMLOG Guide: COLOR IMPLANT DIAMETER yellow 3.8 mm red 4.3 mm Further information about CAMLOG products is available in the following documentation: Current CAMLOG product catalog Working instructions Preparation instructions Instruction manuals (included with CAMLOG products as package inserts) The documents are available from your local CAMLOG representative. See also and Further information about the 3D planning software and the tubing positioning system used is available in the manufacturer s user documentation.

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22 TRADE NAMES AND COPYRIGHT Protected trade name (trademarks) are not specially indicated. The absence of such notes may not be interpreted to mean that a trade name is unregistered. This document, including all its parts, is protected by copyright. Any use beyond the restricted limits of the copyright law without the agreement of CAMLOG Biotechnologies AG is not permissible and is punishable by law.

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24 Art.No. J Rev.1 06/2010 HEADQUARTERS CAMLOG Biotechnologies AG Margarethenstrasse 38 CH-4053 Basel Phone Fax Manufacturer of CAMLOG products: ALTATEC GmbH, Maybachstraße 5, D Wimsheim