Titanium Base for CAD/CAM For single-tooth and bridge solutions

Titanium Base for CAD/CAM For single-tooth and bridge solutions SWISS PRECISION AND INNOVATION. SWISS PRECISION AND INNOVATION.

Notes EXPLANATION OF SYMBOLS Batch code Use by date Date of manufacture RESPONSIBILITY/LIABILITY As part of an overall scheme, Thommen implants may be used only with the ori ginal components and instruments in accordance with the manufacturer s instructions. The use of unapproved components from other systems can cause malfunctioning of the implants and abutments and lead to implant failure. The use of the product is the responsibility of the user and, as such, beyond the control of Thommen Medical AG. We refuse to accept any re sponsibility or liability for any damage due to incorrect utilization of the product. Sterilized using irradiation Upper limit of temperature Do not re-use Products labeled Do not re-use may not be refurbished and/or reused. The refurbishment and/or reuse of these products can affect their function (fitting and/or cutting properties) as well as their safe use (risk of infection, fading of the laser or colour marks, corrosion). Detailed information about the possible conse quences, which may result from negligence to follow this information, is avail able from your dealer. Non-sterile Caution Catalogue number Conformity symbol as specified by EU Directive MDD 93/42/EEC Consult instructions for use Do not resterilize Do not use if package is damaged Atmospheric pressure limitation Manufacturer COLOUR CODE Each implant platform diameter has a colour code, which can be found on all implant packs, on the impression items and on most diameter-specific instruments. GUARANTEE OF STERILITY OF STERILE PRODUCTS Products of the Thommen Implant System supplied in sterile packaging must not be resterilized. If the sterile packaging is damaged during transport or storage, the product must not be used. Products that have been opened and have not been immediately used for the intended operation must not be used thereafter. After resterilization, the safety, function and efficacy of the product cannot be guaranteed by the man ufacturer. STORAGE Plastic parts must be stored at room temperature and protected from exposure to strong light or high heat. Temperature limitations as specified on the packaging must be observed. INSTRUCTIONS FOR USE The following information is not intended as com prehensive for the Thommen Implant System. New customers are advised to undergo training by a specialist experienced in the use of this system. VALIDITY This product catalogue replaces all previous editions. PRODUCT DOCUMENTATION You can find detailed information on the han dling of Thommen implants in our brochures. Ask our national representatives for product brochures and instructions for use. AVAILABILITY NOTE Not all products shown in this brochure are available in all countries. For further information please contact our subsidiary or distributor in your country. Yellow = platform 3.5 mm Green = platform 4.0 mm Blue = platform 4.5 mm Grey = platform 5.0 mm COPYRIGHT /REGISTERED SPI, INICELL, APLIQUIQ and Remotis are registered trademarks of Thommen Medical AG. Publication or reproduction is permitted only with the written consent of Thommen Medical AG. LOCATOR is a registered trademark of Zest Anchors Inc., CA, USA. COLOURED WARNING STICKER Application was changed follow the instructions in the corresponding docu mentation. Violet = platform 6.0 mm New design the application has not been changed.

Contents Titanium Base for CAD/CAM 4 Fabrication of customized abutments 6 Adhesive bonding methods for screw-retained bridge restorations 10 Fabrication of the restoration 14 Insertion of the restoration 16 Product overview 18 Thommen Medical 3

Titanium Base for CAD/CAM For single-tooth and bridge solutions The titanium base for CAD/CAM solutions facilitates the production of customized ceramic abutments for Thommen implants. Optimal anatomical crown contours and highly esthetic colouring in the collar area can be achieved by using titanium base and the custom-manufactured abutment. Screw-retained bridge restorations can be manufactured by using the titanium base bridge. The titanium base is manufactured with the highest precision to meet the exacting requirements of the Thommen Implant System. Precise tolerances ensure a reliable implant abutment connection. Advantages at a glance Compatible with a wide range of CAD/CAM systems Individualized emergence profile with an optimal anatomical shape Tooth-coloured abutments allow for supragingival abutment-crown transitions Direct bonding possible for screw-retained bridge r estorations Flexible fabrication process allows in-house/partial/ out-sourced manufacturing 4 Thommen Medical

Indications Bonding bases for manufacturing individual abutments made of zirconium dioxide, crown and bridge restorations for Thommen implants. e.g. single-tooth restorations screw-retained cemented Titanium base with hexagon Screw-retained single-tooth restoration: CAD/CAM zirconium dioxide superstructure and directly veneered crown bonded to titanium base Cemented single-tooth restoration: CAD/CAM zirconium dioxide superstructure bonded to titanium base, with full-ceramic crown Cemented bridge restoration: CAD/CAM zirconium dioxide superstructure bonded to titanium base, with ceramic bridge framework Titanium base bridge Screw-retained bridge restoration: Porcelain bridge directly bonded to titanium bases Contraindications Cantilevered restorations on a single implant Titanium base hexagon: for screw-retained singletooth and cemented bridge restorations Titanium base bridge: for screw-retained bridge restorations A B Conical/parallel segment for customized superstructure 4.5 mm Positioning index Implant shoulder 0.7 mm Cone Hexagon platform Titanium base hexagon and titanium base bridge have the same dimensions from the implant shoulder: PF 3.5 mm PF 4.0 mm PF 4.5 mm PF 5.0 mm PF 6.0 mm A 0.65 mm 0.70 mm 0.95 mm 1.20 mm 1.70 mm B 2.45 mm 2.90 mm 2.90 mm 2.90 mm 2.90 mm Thommen Medical 5

Fabrication of customized abutments Laboratory For some CAD/CAM systems, a full-contour (diagnostic) wax-up of the definitive restoration is recommended. In this case, the wax-up is shaped right on the titanium base and then scanned. The positioning index undercut must be filled prior to shaping. The following procedure using the scan abutment is suitable for most current CAD/CAM systems. Alternative procedures should be discussed directly with the provider of CAD/CAM services. 1. Production of the model A gingival mask (gingival simulation material) is recommended. The procedure for production of the model is described in the brochure SPI VARIO SPI RETAIN Fo_22d010. 2. Checking the scan abutment The Thommen scan abutment is made from a plastic material that may be scanned directly and is also reusable. A scan-enhancing coating is not required. Prior to the scanning process, the abutment should be visually checked for signs of wear (connection geometry) and surface damage (scan area). Some systems may scan the titanium base directly, as an option. In this case, a coating spray is normally required. 3. Positioning the scan abutment The scan abutment is used to detect the position of the implant on the working model. The flat surface on the scan abutment corresponds to the location of the positioning element on the titanium base. The flat surface must be located in palatinal/lingual orientation in the model. The abutment is fastened on the analog by hand and with barely noticeable torque using an extra-short screw for impression coping. 4. Scanning The scanning process should be performed in accordance with the instructions of the CAD/CAM system provider. 6 Thommen Medical

5. Additional data collection The geometric data obtained by the scan abutment and other scanning processes e.g. occlusal relation index, gingival mask, etc. are required for manufacturing an individual abutment using the CAD/CAM process. 6. Abutment and framework design The zirconia superstructure is constructed on a computer using CAD software. The following restoration options are available: Screw-retained restorations: Designs for abutments respectively crowns or bridge frameworks are made according to the requirements for direct veneers. In the case of bridges, the framework is manufactured first. The titanium base is not bonded to the abutment, respectively crown or bridge until after completion of the framework veneer. Cemented restorations on individual abutments: Individual abutments for cement retained porcelain crowns or bridges require attention to the design (margin location, chamfer and path of placement). The titanium base and the custom-manufactured zirconia superstructure are bonded together before the crown or bridge is manufactured. In general: The titanium base bridge is exclusively used for multi-unit screw-retained bridge restorations. It is necessary to comply with the minimum wall thickness of a custom-manufactured abutment, crown or bridge framework made of zirconium dioxide. Please comply with the recommendations of the supplier of the respective material. Leading and established CAD/CAM providers already include the Thommen titanium base in their software library. Thommen Medical will continue to supply this data to additional CAD/CAM services providers. See list of providers at www.thommenmedical.com. 7. Fabrication of the customized abutment The detailed procedure for producing meso- or superstructures depends on the CAD/CAM system that is used and is beyond the scope of the present brochure. For information about corresponding procedures and details, please refer to the user documentation and software of the various providers of such systems. Alternative procedure: Copy milling The titanium base can also be used in a copy-milling process. The laboratory screw for PF 3.5 mm or PF 4.0 6.0 mm serves to fix the titanium base on the analog and, in addition, provides for a precisely defined screw channel during the modeling of the abutment. Thommen Medical 7

A 8. Preparation of the titanium base for the blasting process The margin, connection geometry and the screw channel of the titanium base must not be damaged during the blasting process. To protect the connection geometry, the titanium base is screwed onto an analog using the matching abutment screw. The margin of the titanium base (A) should be covered with a suitable masking material before performing the blasting procedure. For ease of handling, the analog with the screw-retained titanium base can be attached to the dental laboratory handle. 9. Blasting process Blast the bonding sites of the titanium base and zirconia superstructure briefly with 50 μm aluminium oxide at a max. pressure of 2 bars. 10. Cleaning After sandblasting, the titanium base and zirconia superstructure are cleaned using steam jet or alcohol. All residual dust and grease must be removed from the surface. 11. Cement preparation and application To bond the titanium base to the superstructure, we recommend the 70.0 mm cylindrical pin for laboratory, available for platform sizes 3.5 mm and 4.0 6.0 mm. Once it has been shortened to the desired length and inserted into the screw channel, the cylindrical pin keeps the screw channel free from cement material. The cylindrical pin is made of PTFE and does not form a bond with the cement. The cylindrical pin is easy to remove after the bonding process is complete. Thommen Medical recommends PANAVIA F 2.0 made by KURARAY or RelyX Unicem made by 3M for bonding the titanium base to the superstructure. The cement is mixed according to the manufacturer s instructions. It is then applied to the bonding areas of the titanium base and zirconia superstructure. 8 Thommen Medical

12. Bonding the superstructure to the titanium base Push the superstructure over the cylindrical pin down onto the titanium base until resistance is felt. Turn the superstructure until it clears the positioning index and seats completely on the titanium base. When bonding on the model: Push the superstructure over the cylindrical pin and the titanium base. Press, exerting slight pressure, into the end position. 13. Removing residual cement agent Remove any excess of cement from the margin with an appropriate instrument before it sets. 14. Curing the cement and finishing Light-cure the cement or, with self-curing cements, allow sufficient time for curing. Please comply with the processing instructions of the respective manufacturer. Remove the cylindrical pin for laboratory after the cement has cured. Carefully remove any residual cement under the microscope with a rubber-polishing bur/wheel. 15. Further processing The customized abutment is now ready for further processing. Clinical images courtesy of Rübeling + Klar Dental-Labor GmbH & Co. KG, Berlin, Germany Thommen Medical 9

Adhesive bonding methods for screw-retained bridge restorations The titanium base bridge is used exclusively for multi-unit screw-retained bridge restorations. Please note the following two prerequisites: The alignment of the screw channel has to be occlusally located in posterior restorations and palatal/lingual in anterior restorations. The planned bridge construction has to be suitable for a direct veneer (screw-retained restoration). If these prerequisites are not met, do not proceed with a screw-retained restoration and to switch to a cemented bridge construction. Be sure to identify the correct bonding method for a screw-retained bridge prior to construction. Good preparation prevents unpleasant surprises during the subsequent bonding process. Two bonding methods are available: Bonding on the model Bonding off the model To determine the correct bonding method, we recommend the following approaches. Determination for bonding method on the model Bonding on the model is feasible only if a path of placement between the bases is achievable. This bonding method strongly depends on implant divergences. The bridge must not be retouched or, at most, only minimally. 1. Assembling titanium bases Position the titanium bases on the laboratory analog in the model and fix with abutment screws. 2. Measuring Check and determine the path of placement of the bridge on the parallelometer. 3. Determining the bonding method If you notice substantial undercuts in the path of placement be - tween the bridge and titanium bases, you must switch to the off the model-bonding method. 10 Thommen Medical

Bonding procedure on the model 1. Assembling titanium bases Remove the gingival mask from the model. Completely remove the positioning index from the titanium bases with a rubber wheel. Attach the titanium bases to the laboratory analogs in the model. Fix with abutment screws. 2. Seating the bridge construction The bridge construction can be slightly adjusted to achieve path of placement. Take care to seat the bridge correctly. The fit between the bridge and the titanium bases must be passive for successful bonding. 3. Preparing titanium bases for bonding Perform steps 8 10 on page 8. Reposition the titanium bases on the model and fix with abutment screws. Verify correct seating of the bridge. 4. Bonding On the model, seat the bridge construction through the cylindric al pins onto all the titanium bases at the same time (steps 11 14 on page 8 and 9). Thommen Medical 11

Preparation for the bonding method off the model We advise bonding off the model if path of placement is not achievable. With this method, the titanium bases are bonded to bridge while off the model then transferred back to the model while the cement is still pliable. The cement achieves final cure with the bridge on the model. The titanium base bridge enables the bridge to be inserted/removed on implants which diverge by up to 30. The technique below will verify the path of placement and acceptable divergence of the implants. 1. Assembling titanium bases Fix the titanium bases on the lab analogs with laboratory screws. When using abutment screws, ensure that the screw channels are kept absolutely clear. 2. Splinting the titanium bases Rigidly splint the titanium bases together on the model with a suitable pattern resin (use a strengthener if required). 3. Checking the construction Loosen the laboratory or abutment screws and remove the splinted seating index from the model. If the construction (simulated bridge) can be removed and replaced with reasonable ease, the path of placement should be acceptable when the finished bridge is inserted. Tip: Create an anatomically correct seating index for cases with slanting adjacent teeth. This will identify seating interferences and determine the exact path of placement of the planned bridge. Note: If neither bonding method is possible due to large divergences between implants, a cemented bridge with individual abutments is recommended. 12 Thommen Medical

Bonding off the model 1. Preparing titanium bases for bonding Perform steps 8 10 on page 8. Proceed to disassemble the analogs from the titanium base which were used for the sandblasting process. Remove the gingival mask from the model. 2. Inserting the cylindrical pin for laboratory Shorten the cylindrical pin for laboratory to the desired length and insert into the titanium base. 3. Mixing and applying the adhesive Mix the adhesive components and apply carefully to the bonding surfaces of the titanium base and bridge abutments. 4. Placing the titanium bases in the bridge Working off the model, place each titanium base with inserted cylindrical pin into the corresponding bridge abutment. For bonding see section 12 and 13, page 9. During steps 4 and 5 the adhesive still needs to be in a pliable state! 5. Positioning the bridge on the model When all the bridge abutments have received titanium bases, align the bridge construction in the analogs on the model. Verify correct and complete seating. Proceed to remove cylindrical pins for laboratory, insert the abutment screws and tighten. 6. Curing the adhesive and finishing See step 14 on page 9. Thommen Medical 13

Fabrication of the restoration Laboratory Option 1: occlusal screw-retained The custom-made ceramic abutment is directly veneered and fi nished prior to being bonded to the titanium base with hex. For occlusal screwretained bridges, the custom-made ceramic framework is directly veneered and fi nished prior to being bonded to the titanium base bridge. 1. Veneering ceramic abutment or framework Provide an orifi ce in palatinal, lingual or occlusal position to allow the ready-made crown to be fi xed on the implant with an abutment screw. Fix the titanium base with the laboratory screw (see below) for PF 3.5 mm or PF 4.0 6.0 mm onto an analog. While applying the veneering ceramic to the custom-made abutment or framework, the laboratory screw keeps the screw channel free of veneering material. 2. Bonding Bond the veneered superstructure (crown) onto the titanium base, using the cylindrical pin for dental laboratory (for description, see pages 8, 9) to keep the screw channel clear. 3. Finishing Finish and clean the crown and send it to the dentist. PF 3.5 mm Identifi cation grooves PF 4.0 6.0 mm Benefits of the laboratory screw Can be fastened and removed with just a thumb and index fi nger Rapid and secure fi xation since it has a short thread (approx. 2 turns) Laboratory screw fi ts in all available analogs and abutments made by Thommen Medical with the exception of the scan abutment The 25.0 mm length allows for the use of laboratory screw as a modeling aid Easy identifi cation of the two screws by means of grooves on the end of the shaft 14 Thommen Medical

Option 2: cement retained The porcelain crown or bridge is cemented intraorally onto the individual abutment(s). The procedure described below also applies to cemented bridge restorations. 1. Bonding Bond the customized ceramic superstructure to the titanium base (for description, see pages 8, 9). 2. Modeling Shape the full-ceramic crown, or crown/bridge framework conventionally or by using a CAD/CAM process. 3. Fabrication The crown/bridge framework is manufactured conventionally or with the miling unit if the CAD/CAM process is used. Veneering is done afterwards. 4. Finishing Completed crown/bridge is forwarded to the dentist along with the individual abutment(s) for insertion and cementation. Tip: On bridges, a seating index made from pattern resin is recommended for locating individual abutments intraorally. Thommen Medical 15

Insertion of the restoration Dentist Option 1: occlusal screw-retained 1. Removing the temporary restoration Remove the gingiva former or temporary crown(s)/bridge from the implant. Clean and dry the inner configuration of the implant thoroughly before attaching the permanent crown or bridge. 2. Positioning the crown/bridge Position the clean crown/bridge on the implant(s) and check for correct seating. It is important to ensure that no soft tissue is pinched. Proper seating of the abutment can be verified by radiograph. 3. Fixing the crown/bridge For permanent insertion, it is essential to use new abutment screws. The torque of the abutment screws on crowns/bridges with a titanium base is 15 Ncm for PF 3.5 mm and 25 Ncm for PF 4.0 6.0 mm. 4. Sealing the screw channel After inserting the restoration, refill the screw channel with a removable material (e.g. gutta-percha). Seal the screw channel with a suitable composite material. Note Do not autoclave the titanium abutment and zirconia coping after bonding. 16 Thommen Medical

Option 2: cement retained 1. Removing the temporary restoration Remove the gingiva former or temporary crown(s)/bridge from the implant. Clean and dry the inner configuration of the implant thoroughly before attaching the permanent crown or bridge. 2. Positioning the abutment(s) Position the clean custom-made abutment(s) onto the implant(s) and verify complete seating and fit. It is important to ensure that no soft tissue is pinched. Proper seating of the abutment can be verified by radiograph. 3. Fixing the abutment(s) For permanent insertion, it is essential to use new abutment screws. The torque of the abutment screws for individual abutments with a titanium base is 15 Ncm for PF 3.5 mm and 25 Ncm for PF 4.0 6.0 mm. 4. Sealing the screw channel Fill the screw orifice with a removable material (e.g. gutta-percha). 5. Fitting the crown/bridge Cement the porcelain crown or bridge onto an individual abutment or abutments. Carefully remove all residual cement. Note Do not autoclave the titanium abutment and zirconia coping after bonding. Thommen Medical 17

Product overview PF 3.5 mm PF 4.0 mm PF 4.5 mm PF 5.0 mm PF 6.0 mm Titanium base with hexagon, for CAD/CAM, abutment screw incl., Titanium 1.04.750 1.04.751 1.04.752 1.04.753 1.04.754 Titanium base bridge, for CAD/CAM, incl. abutment screw, Titanium bild?? 1.04.760 1.04.761 1.04.762 1.04.763 1.04.764 Scan abutment, PEEK 2.03.770 2.03.771 2.03.772 2.03.773 2.03.774 Laboratory screw, Stainless steel Length 25.0 mm 3.03.515 3.03.516 3.03.515Q5 3.03.516Q5 Abutment screw, 4-lobe, Titanium alloy Length 5.8 mm 4.03.500 7.2 mm 4.03.501 10.2 mm 4.03.502 Screw for impression copings, reusable, 4-lobe, Stainless steel Length 27.5 mm extra long 3.03.580 21.5 mm long 3.03.574 16.5 mm short 3.03.573 12.5 mm extra short 3.03.572 28.2 mm extra long 3.03.581 22.2 mm long 3.03.577 17.2 mm short 3.03.576 13.2 mm extra short 3.03.575 18 Thommen Medical

PF 3.5 mm PF 4.0 mm PF 4.5 mm PF 5.0 mm PF 6.0 mm Analog, Titanium Length 14.0 mm 3.03.090 3.03.095 3.03.091 3.03.092 3.03.093 1 22.0 mm 3.03.060 3.03.061 3.03.065 3.03.062 3.03.063 Handle for dental laboratory, Brass/steel Length 120.0 mm 3.03.250 Cylindrical pin for dental laboratory, PTFE Length 70.0 mm 2.03.450Q5 2.03.451Q5 Q5 = 5 units (packaging unit) 1 Due to design, overall length 15.0 mm Thommen Medical 19

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