Overview on complete guided surgical protocol for partially edentulous cases with NobelReplace® Straight, Replace Select™ Straight and NobelSpeedy® Replace

Caution The NobelGuide system was developed for implants launched in 2005. This means that drills and the drilling protocol are tailored for the „Groovy“ implants. If previous versions of the implants are used („Select“), carefully compare the measurements. Replace Select Straight has a 0.3 mm wider body than the NobelReplace Straight Groovy version in the RP platform. In dense bone situations, this might lead to an under-preparation of 0.3 mm when using Replace Select Straight implants in combination with NobelGuide.

Required implants and instruments The following implants and instruments are required for implant placement: NobelReplace Straight Guided Surgery Kit, including instruments for planned implants (NP, RP, WP, 6.0) Guided Drill Stop Kit Disposable drills for selected implant dimensions and bone density NobelReplace Straight Groovy, Replace Select Straight or NobelSpeedy Replace implants Abutments

Drilling sequence The following procedure and illustrations show the use of NobelReplace Straight Groovy RP x 13mm implants in medium bone. I a I b I c II b II c* II a III

Drilling sequence according to bone quality+ Platform Ø Implant Soft bone Medium bone Dense bone** NP 3.5 Ø 2.0 Ø 2.8 RP 4.0 Ø2.0 (Ø 2.8) Ø 3.2 Ø 3.4 WP 5.0 Ø 3.0 Ø 3.8 Ø 4.2 All data in mm. Drills within brackets (- -) denote widening of the cortex only, not drilling to the full drilling depth. Note: The diameter of the implant body of Replace Select Straight RP is 0.3mm wider than the one of NobelReplace Straight RP. This needs to be taken into consideration in dense bone situations as there is a risk of under preparation when using the RP implant diameter. + Please consult the instructions for use when determining drilling protocol.

Common drilling considerations Note: (10+) indicates the drills extend an additional 10mm Guided Twist Drill 3 x (10+) 7-18 mm Guided Twist Drill 3 x (10+) 7-13 mm

Surgical access: I a, I b, I c Flap procedure (flap, mini-flap): Keratinized tissue may be saved. Submerged placing of the implant is also possible (allowing for simultaneous bone augmentation procedures, etc.) by using a mini – flap or flap (I a). Flapless procedure: If a flapless procedure is chosen, it is recommended to use a soft tissue punch before any other instruments are used to generate a clean cut (I b or I c). The surgical template is temporarily detached after punching to carefully remove the punched tissue. The surgical template is repositioned carefully using the same surgical index and placing the anchor pins into the existing anchorage holes in the bone. I a I b I c II a II b II c* III

Drilling: II a, II b, II c II a: Drilling sequence with Guided Start Drill and the 7 – 13 mm or 7 – 18 mm Guided Twist Drills, depending on the planned implant II b: Dense bone protocol to be used when implant will not be fully seated. Select the Guided Screw Tap matching the diameter of the implant II c: The Guided Start Drill / Counterbore (single use) is recommended to be used as a countersink (maximum 800 rpm) at the end of the drilling procedure to create adequate access for the Guided Implant Mount I a I b I c II a II b II c* III

Implant insertion: III Place and tighten implant using maximum 45 Ncm installation torque. Caution: Never exceed insertion torque of 45 Ncm. Over-tightening an implant may lead to damage of the implant, fracture or necrosis of the bone site. Note: For further information, please refer to Instructions for Use NobelReplace Straight Groovy, NobelSpeedy Replace and NobelGuide. I a I b I c II a II b II c* III

Position surgical template Carefully and correctly position and secure the surgical template using the surgical index and anchor pins Maximum speed 800 rpm

Access soft tissue Flapless: (Mini –) flap: Punch soft tissue without removing surgical template (Mini –) flap: Remove surgical template Raise flap Ensure correct position of surgical template can still be achieved Reposition surgical template using same anchor pin holes Flapless (Mini –) flap

Drill with Guided Twist Drill Start drilling one implant first, from start to finish, including guided implant insertion Place the Guided Drill Guide RP to Ø 2 mm in the selected template sleeve Drill with the Guided Start Drill to the built-in drill stop Maximum speed 800 rpm

Drill with Guided Twist Drill Mount a Drill Stop Ø 2 mm on the Guided Twist Drill Ø 2 x (10+) 7 – 18 mm for a safe and accurate drilling procedure Place the Guided Drill Guide RP to Ø 2 mm in the selected template sleeve Drill with the Guided Twist Drill Ø 2 x (10+) 7 – 18 mm to the desired depth with an in-and-out motion under profuse irrigation using the drill guide for guidance Maximum speed 800 rpm

Drill with Guided Twist Drill Notes: The depth markings on the twist drill correspond to 7, 10, 13, 15 and 18 mm implants and should be measured while level with the drill guide When using the twist drills, use copious irrigation and an “in-and-out” drilling motion with emphasis on bringing the tip of the drill out of the template when preparing the site to avoid overheating A (10+) indicates that the drills extend an additional 10 mm Warning: During surgery maximum attention must be paid to ensure that the surgical template does not move in any direction from the correct position when being manipulated with instruments, e.g. lateral shift through inadequate handling of (pilot) drill in “knife – edge” situations or shift / deformation of surgical template due to excess vertical force application during implant installation. 7 mm 10 mm 13 mm 15 mm 18 mm

Continue drilling Mount the Drill Stop Ø 3.2 mm on the Guided Twist Drill 3.2 x (10+) 7 – 18 mm for a safe and accurate drilling procedure Place the Guided Drill Guide RP to Ø 3.2 mm and drill to the stop with the Guided Twist Drill 3.2 x (10+) 7 – 18 mm Maximum speed 800 rpm

Option: Dense bone situations The screw tap should be used in all sites where the bone is dense or locally dense Use the Guided Screw Tap RP Ø 4, 7 – 13 mm in sites where an implant “gets stuck” before being properly seated and would require more than 45 Ncm of torque to seat Low speed – maximum 45 Ncm Switch handpiece to reverse mode and back screw tap out If the implant does not seat after using the screw tap, widen the site with the next drill on the drilling protocol, then use the screw tap again

Option: Counterbore Use Guided Start Drill / Counterbore RP: As a countersink at the end of the drilling procedure If the implant shoulder was placed below the crest to generate adequate access for the Guided Implant Mount during implant insertion Maximum speed 800 rpm

Implant insertion Open package Open the outer packaging of the implant Empty the inner sterile container with the implant onto the sterile field Remove the plastic cylinder Notes: Each implant is packaged in a double sterile vial The outer package included two printed peel-off labels with product date, which can be affixed to the patient chart The cap of the outer package is color-coded to identify the implant platform Cover screw is not included with the NobelReplace Straight and NobelSpeedy Replace implants For the Replace Select Straight implant, the cover screw is co-packed in the enclosed compartment on top if the titanium casing

Connect the implant mount Use Unigrip screwdriver and the surgical adapter from the Manual Torque Wrench to connect the Guided Implant Mount NobelReplace RP to the implant Ensure precise fit of the implant mount and the implant Note: Guided Implant Mounts are screw-retained to ensure correct depth stop and prevent implant disconnection from Guided Implant Mount when over-torquing. However, over-torquing must be avoided at all times.

Pick up the mounted implant Use the NobelReplace Connection to Handpiece

Insert the mounted implant Use the NobelReplace Connection to Handpiece Insert the implant until the flange of the implant mount touches the top of the sleeve in the surgical template Avoid further tightening of the implant as it might affect the correct position of the surgical template Note: The dots on the implant mount indicate the position of the internal tri-channel connection lobes.

Anchor the surgical template Use a Guided Template Abutment NobelReplace RP Tighten manually using a Unigrip screwdriver Ensure that the surgical template maintains its initial correct position for the next implant site preparation

Install remaining implants Proceed with preparation of the remaining implant sites Install the remaining implants according to the previously described procedure Notes: Place template abutments on the first two implants. After placement, leave the seated implant mounts in their final position until all implants are placed If only two implants are to be placed, there is no need for a template abutment on the second implant

Remove surgical template Remove the implant mounts and template abutments after all implants have been placed Remove the anchor pins and the surgical template Note: Consider the usage of a bone mill with its corresponding guide to enable correct abutment seating

BACK-UP

Drill sequence for NobelReplace Straight® RP x 13mm „Cheat sheet“ for hands-on exercise Surgical access Guided Start Drill 800rpm Guided Twist Drill Ø 2mm 800rpm Guided Twist Drill Ø 3.2mm 800rpm Guided Screw Tap RP Ø 4mm 45Ncm Counterbore RP 800rpm Implant insertion 45Ncm