The Navigator System For Guided Surgery

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Shana Patrick
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1 The Navigator System For Guided Surgery Technica Considerations PLANNING CLINICAL USE PREPARATION

GUIDED IMPLANT TREATMENT Panning It is important for users to become famiiar with the capabiities and imitations of guided surgery systems. Each type of technoogy works within certain parameters.

As a resut, the foowing shoud be considered aong with the Parae Waed Navigator System Manua (ART1019) when treatment panning and performing denta impant cases.

2 GUIDED IMPLANT TREATMENT Panning It is important for users to become famiiar with the capabiities and imitations of guided surgery systems. Each type of technoogy works within certain parameters. Cinicians must ensure that the treatment pan is created in such a way that it wi be cinicay executabe on the day of surgery. As a resut, the foowing shoud be considered aong with the Parae Waed Navigator System Manua (ART1019) when treatment panning and performing denta impant cases. The use of a scanning appiance is required in fuy edentuous cases and recommended in a mutipeunit cases (Fig. 1). Fig. 1 - The scanning appiance and scanning protoco wi be dependent upon the panning software utiized. - Both singe scan (barium-sufate scanning appiance) and dua scan (gutta percha marked scanning appiance) protocos are possibe with the Navigator System. - Create a bite registration from radioucent materia to confirm proper positioning of the scanning appiance during CT scanning. Confirm that the CT scanning appiance fits in the mouth and is seated competey before the scan is performed. Faiure to confirm a stabe fit of the scanning appiance may resut in a poory fitting Surgica Guide, which wi affect the outcome of the procedure. Downoad the most recent version of panning software incuding impant ibraries. 1

2 Impant Seection Screen in SimPant Software; courtesy of Materiaise Denta. Consider interarch space when panning in the posterior.

3 The treatment pan must incude denta impants that are compatibe with the Parae Waed Navigator System (Fig. 2). Fixation points panned into the vestibuar aspect of the Surgica Guide aow for insertion of fixation screws whie the patient occudes into the bite registration. Fig. 2 Impant Seection Screen in SimPant Software; courtesy of Materiaise Denta. Consider interarch space when panning in the posterior. A systems that utiize Surgica Guides wi require ong dris to accommodate the additiona vertica ength required to pass through the Surgica Guide and soft tissue. The ength of the dri specified is a factor of the impant ength seected by the cinician, with the position of the Master Tube determined by the Surgica Guide manufacturer (Fig. 3). Pease seect appropriate impant engths when treatment panning. Currenty, the Parae Waed Navigator System is compatibe with the foowing BIOMET 3i Impants: - Certain Interna Connection 3.25, 4.0 and 5.0mm Parae Waed Impants - PREVAIL 3/4/3, 4/5/4 Impants and OSSEOTITE XP 4/5 Impants - Straight Coar PREVAIL 4/3 and 5/4 Impants Currenty, the foowing impants are NOT compatibe with the Parae Waed Navigator System: - Tapered Impants - 6.0mm impants or impants that have a 6.0mm diameter coar (PREVAIL 5/6/5) - 7.0, 18.0 and 20.0mm ength impants - Externa hex connection impants - Certain Interna Connection 5.0mm Parae Waed and Straight Coar PREVAIL 5/4 Impants in 15.0mm engths Presenty, Parae Waed Navigator Instrumentation does not support subcresta pacement of 3.25mm diameter impants. Surgica Guide fixation is required for tissuesupported cases and recommended for tooth- and bone-supported cases to minimize Surgica Guide movement during surgery mm bone screws assist with the stabiization of the Surgica Guide. Points of fixation can be panned into a Surgica Guide during treatment panning within the software. The Surgica Guide manufacturer determines the distance that the Master Tube is positioned above the impant patform. The distance between the top of the Master Tube and the impant patform is variabe at the foowing engths: 7.5, 9.0, 10.5 and 12.0mm. With the Parae Waed Navigator System, impants are guided into position through the Surgica Guide with Impant Mounts. Guided pacement of the impants to the intended depths may not be possibe if impants are panned too deep. A maximum depth of 12.0mm through the Surgica Guide to the seating surface of the impant is possibe. Pease keep this in mind during case panning. Fig. 3 Orthodontic wire may provide additiona Surgica Guide stabiization for toothsupported cases. - Use of a bite registration in occusion is required for tissue-supported cases to ensure proper positioning of the Surgica Guide during bone screw fixation. 2

GUIDED IMPLANT TREATMENT Panning (Cont d) When working in tight interdenta spaces, provide sufficient space for the Master Tube to fit between existing dentition or cosey panned impants.

5mm for the tube itsef with 1.0mm of space on either side) (Fig. 4). The 4.0mm Master Tube is used for impants with coar diameters of 3.4 and 4.1mm. The 5.

4 GUIDED IMPLANT TREATMENT Panning (Cont d) When working in tight interdenta spaces, provide sufficient space for the Master Tube to fit between existing dentition or cosey panned impants. For a singe-unit case, a cinician wi need spacing of at east 7.5mm for a 4.0mm Master Tube (5.5mm for the tube itsef with 1.0mm of space on either side) and 8.5mm for a 5.0mm Master Tube (6.5mm for the tube itsef with 1.0mm of space on either side) (Fig. 4). The 4.0mm Master Tube is used for impants with coar diameters of 3.4 and 4.1mm. The 5.0mm Master Tube is used for impants with a coar diameter of 5.0mm. When panning to immediatey provisionaize Navigator Cases, consider the foowing factors that may hep to indicate primary impant stabiity: - Bone density readings (in Hounsfied Units) from a CT scan. - Potentia impant ength and position reative to the restoration. 7.5mm - The use of screw-retention in combination with a fu arch cement-retained restoration. The screwretained sites shoud be panned at ocations with the highest anticipated initia stabiity. Fig. 4 For mutipe-unit cases, you must consider mesia dista inter-impant spacing. Measuring from the center of a panned impant to the center of an adjacent impant, 7.1mm is needed between 4.0mm impants, with 8.0mm needed between 5.0mm impants (Fig. 5). 7.1mm Fig. 5 3

GUIDED IMPLANT TREATMENT Preparation Inspect the Surgica Guide for imperfections and reinforce potentia weak areas of the Surgica Guide with acryic.

positioned intraoray. Inspect the Master Tubes to ensure that no fabrication materia remains from the Surgica Guide manufacturer. manufacturer wi contact you.

5 GUIDED IMPLANT TREATMENT Preparation Inspect the Surgica Guide for imperfections and reinforce potentia weak areas of the Surgica Guide with acryic. Prior to surgery, try-in a Dri Positioning Hande in each Master Tube to determine if the Surgica Guide needs adjustments to aow the Dri Positioning Handes to fuy seat once the Surgica Guide is positioned intraoray. Inspect the Master Tubes to ensure that no fabrication materia remains from the Surgica Guide manufacturer. manufacturer wi contact you. You may modify the case pan by changing the ength of the impant seected or repositioning the impant to fit within the parameters of the dris incuded in the Navigator Surgica Kit (dris A-E). When changing impant ength, a size onger or a size shorter impant wi be compatibe with the system. If modifying the case is not preferabe, you may purchase the required Y or Z Dris by contacting your oca saes representative or Customer Service at or outside the U.S. at Score the Master Tube notch position on the Surgica Guide to record the hex-orientation andmarks (Fig. 6). Fig. 6 To verify hex orientation at the time of impant pacement, a periodonta probe or curette wi confirm aignment of the Impant Mount and Master Tube by engaging the aigned sots. Fig. 7 The Parae Waed Navigator Surgica Pan, which specifies the use of (Z) ength Twist Dris. Preparation of a master cast may be advised to confirm the panned position and restorative considerations of the impants prior to surgery. Review the CT scan data for bone density to anticipate areas of poor quaity bone and areas where impant stabiity may be compromised. During use, driing and pacing the impants through the Master Tubes in the Surgica Guide provide itte tactie confirmation of bone density. A imited number of cases wi require the use of a Twist Dri(s) in a ength(s) that is not incuded within the Parae Waed Navigator Surgica Kit. These dri engths are specified as Y and Z dris (Fig. 7). If your treatment pan requires one of these dris, your case wi be put on hod and the Surgica Guide 4 If the Surgica Guide manufacturer receives a pan that is not compatibe with the parameters of the Parae Waed Navigator System, the Surgica Guide manufacturer wi pace the case on hod and contact the customer. As a resut, the customer may be required to modify and resubmit the treatment pan to the Surgica Guide manufacturer. Pease note that if the Surgica Guide manufacturer paces the case on hod, there may be a deay in the origina shipment schedue. If changing the case pan is not possibe, an aternative Surgica Guide may be created for where the Master Tube (guide) for that specific site is excuded from the Surgica Guide.

GUIDED IMPLANT TREATMENT Cinica Use For fapess cases, use a Tissue Punch prior to fixation of the Surgica Guide. Remove the Surgica Guide and the tissue pugs. Then repace and fixate the Surgica Guide.

6 GUIDED IMPLANT TREATMENT Cinica Use For fapess cases, use a Tissue Punch prior to fixation of the Surgica Guide. Remove the Surgica Guide and the tissue pugs. Then repace and fixate the Surgica Guide. The Tissue Punch shoud not be used at speeds greater than rpm. The Tissue Punch and Starter Dri shoud not be used beyond the prescribed depth ine, as this may reduce the cutting efficiency of the instrument or compromise the osteotomy. The fina dri diameters specified on the Parae Waed Navigator Surgica Pan are recommended for use in medium bone densities. In soft or dense bone scenarios, the cinician shoud size the osteotomy to be in ine with the standard driing protocos for those bone types. The corresponding Navigator Dri and Hande Combination shoud be seected accordingy. For further information regarding driing protocos by, pease refer to the Surgica Manua (CATSM). A instrumentation shoud be advanced as far as possibe through the Master Tube(s) or the Dri Positioning Hande Guide Tube and into the osteotomy prior to activation. This wi imit the possibiity of damaging either the instruments or the tube(s). Use copious irrigation on instruments prior to and during use to provide ubrication and cooing when passing through the Master Tube(s) and/or Dri Positioning Hande. Pre-driing access hoes beow and/or adjacent to the Master Tube(s) may be considered to promote site irrigation. NOTE: The Parae Waed Navigator System does not support a soft bone protoco for PREVAIL 4/5/4 and OSSEOTITE XP 4/5 Impants. Sequence the pacement of impants in an aternating cross arch pattern, moving from one side to the other so as to not compress soft tissue. Pace a impants cose to the fina vertica position with the Handpiece, then use the Hand Ratchet to achieve fina vertica position and hex orientation. Pumping the Twist Dris in conjunction with irrigation, aides in the remova of debris from the Master Tube, whie increasing irrigation access into the osteotomy. During impant pacement, once the fange of the Impant Mount contacts the Master Tube, do not continue to torque the Impant Mount. Avoid atera pressure on dris and other instruments, as this may cause damage to the Guidance Tube(s) and instrumentation. If the cinica scenario permits, insert the Twist Dri into the Dri Positioning Hande prior to inserting it into the Master Tube(s) of the Surgica Guide. The Twist Dri/Hande Assemby wi reduce the vertica space required for instrument deivery, whie reducing the ikeihood of exerting atera pressure on the Twist Dri. (Fig. 8) For cases requiring three (3) or more impants, remova of the Impant Mounts immediatey foowing impant pacement may assist with passive Impant Mount remova. If performed, pace two (2) impants with Impant Mounts in a cross arch configuration to assist with stabiization of the Surgica Guide. Remova of successive Impant Mounts wi reduce divergent forces appied to the Surgica Guide. When removing Impant Mounts, remove aong the path of insertion and avoid appying atera force. Use a Bone Profier prior to pacing an abutment of any type. Use an oversized Bone Profier when pacing pre-anged abutments. Fig. 8 5

The screw hed within the Impant and Anaog Mounts is avaiabe in four (4) different engths to accommodate the four (4) vertica positions that a Navigator Master Tube can be paced.

In the case that increased resistance is detected between instruments during surgery, discontinue use and inspect the components for wear or damage.

7 The screw hed within the Impant and Anaog Mounts is avaiabe in four (4) different engths to accommodate the four (4) vertica positions that a Navigator Master Tube can be paced. If disassembing the screw from the Impant or Anaog Mount, ensure reassemby of the correct screw ength with the appropriate mount body (Fig. 9). In the case that increased resistance is detected between instruments during surgery, discontinue use and inspect the components for wear or damage. Do not use non-parae Waed Navigator Dris or Components with Navigator Surgica Guides as a instrumentation is designed specificay to work with the Navigator Master Tubes to maximize accuracy of preparation and pacement of Impants. Navigator Master Tubes (the Surgica Guide) shoud not be used for guidance when driing into a stone or acryic mode, as this may damage the Master Tubes (Fig. 10). Fig. 9 During kit steriization, aow for competion of a fu dry cyce. - Ensure that water does not poo into components that hod water (ie. MDR10). - Take care to remove any bood or debris prior to steriization. A Navigator Instruments are reusabe with required repacement of the Starter Dri and Twist Dri after ten (10) osteotomy preparations. Repacement of Tissue Punches, Impant Mounts, Bone Profiers and Bone Taps is recommended after 15 impant site uses. Fig. 10 Do not use the Navigator Dris on anything other than bone. - Due to the cose interaction of the Navigator Instrumentation with the Master Tube and Dri Guidance Tube, instrumentation wear may be acceerated as compared to non-guided dris and components. - Wear is aso dependent on additiona factors, incuding steriization and bone densities. Dri Positioning Hande repacement is recommended at the time of Twist Dri repacement to ensure optima instrumentation performance, but shoud be used for no more than 15 osteotomy preparations. Inspect a instruments under magnification ( 3x) for wear or damage prior to and foowing surgery. In the case of wear or damage, component repacement is necessary. 6

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8 LOOKING FOR THE LATEST IN ACCURATE IMPLANT TREATMENT? TRY THE NAVIGATOR SYSTEM FOR GUIDED SURGERY! Not Avaiabe In A Markets. Pease Contact Your Loca BIOMET 3i Saes Representative For Avaiabiity Or Visit Goba Headquarters 4555 Riverside Drive Pam Beach Gardens, FL Outside the U.S.: Fax: EC REP BIOMET 3i Europe, Midde East & Africa WTC Ameda Park, Ed. 1, Panta 1ª P. de a Pau, s/n 08940, Corneà de Lobregat (Barceona) Spain Phone: Fax: Join Us Foow Us Watch Us Downoad It Certain, Navigator, OSSEOTITE XP and PREVAIL are registered trademarks of BIOMET 3i LLC. Providing Soutions One Patient At A Time is a trademark of BIOMET 3i LLC. Simpant is a registered trademark of Materiaise Denta BIOMET 3i LLC. A trademarks herein are the property of BIOMET 3i LLC uness otherwise indicated. This materia is intended for cinicians ony and is NOT intended for patient distribution. This materia is not to be redistributed, dupicated or discosed without the express written consent of BIOMET 3i. For additiona product information, incuding indications, contraindications, warnings, precautions and potentia adverse effects, pease visit the BIOMET 3i Website: INST1065 REV A 06/14

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Not Available In All Markets. Please Contact Your Local BIOMET 3i Sales Representative For Availability Or Visit LOOKING FOR THE LATEST IN ACCURATE IMPLANT TREATMENT? TRY THE NAVIGATOR SYSTEM FOR GUIDED SURGERY! www.biomet3i.com Not Avaiabe In A Markets. Pease Contact Your Loca BIOMET 3i Saes Representative For Avaiabiity