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Brånemark System ® and Replace® Implants are FDA cleared for immediate function
for all indications. First from Nobel Biocare

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NobelGuide

QUESTIONS & ANSWERS

Q: What does Nobel Biocare mean with Immediate Function?

A: The term "Function" was selected as it reflects the patient's perspective at implant treatment: Teeth in "function" immediately after implant placement.

Q: What is immediate and what is early?

A: Immediate is within the same procedure (within the same day as the surgery) and early is anything later, but before the recommended of 3-6 months. "Early" should be specified from case to case.

Q: The scientific references show good results with immediate function, but how about the results in daily clinical practice? Is it not a higher risk with immediate function?

A: If the prescribed inclusion/exclusion criteria and protocols are followed, the success rate is similar to that for the two-stage approach. The TiUnite™ and HA surfaces play an important role for this positive outcome.

Most of the clinical studies on Immediate Function are short-term, but it is believed that after the first year of function and bone healing, the prognosis is the same as for the two-stage approach.


Q: In case of complication and litigation, does the FDA clearance have any bearing?

A: No. FDA has only cleared the product for commercial distribution in U.S. based on information from Nobel Biocare, demonstrating the safety and efficacy of the product according to its claims. The user is always responsible for the treatment of the patient.


Q: What is the contingency plan when there is a failure with immediate loading?

A: If one of several implants is lost one may in some cases proceed without that implant. If a crucial implant is lost it can be replaced, immediately with a larger diameter or later with the same diameter.


Q: What are the indications?

A: Candidates for any implant treatment where high implant stability can be achieved and the implant loading can be controlled in the same manner as for a conventional two-stage treatment. See further the Nobel Biocare Immediate Function Guidelines..


Q: Which is the best indication to start with?

A:Partially edentulous patients, from pre-molar to pre-molar in non-esthetically demanding positions and fixed lower bridge or overdenture on implants between mandibular foramina.


Q: What factors in treatment planning are important?

A: There should be sufficient bone at the implant site to allow for a good initial stability. The occusal conditions should be possible to control, i.e. avoiding extreme bruxers, unstable adjacent teeth, long cantilevers etc.


Q: How do I know when an implant is stable enough for immediate function?

A: When an implant insertion torque of 35 – 45 Ncm is achieved before the final seating of the implant neck at the bone ridge.


Q: How does the soft bone react on immediate loading?

A: If an implant with the TiUnite™ surface is used and if the initial stability criterion is reached the implant is likely to have a good prognosis also in soft bone.


Q: Are bone defects exclusion criteria?

A: No. Not as long as the initial implant stability criterion is reached.


Q: What sort of implant do I have to use for immediate function?

A: All Nobel Biocare NP and larger diameter implants are approved for immediate function, but those with TiUnite™ surface are recommended.


Q: What is the best surface for immediate function to use?

A: The best results are achieved with the highly osseoconductive surfaces TiUnite™ or HA.


Q: Does the surgical steps/site preparation differ compared to conventional implant placement?

A: Firm initial stability is of utmost importance. This can be achieved by using tapered implants and/or under-preparation techniques for the parallel wall implants


Q: How should one check the initial implant stability?

A: The clinical documentation shows that high initial stability is indicated by insertion torque values of 35-45 Ncm before final seating of the implant. Most published studies on immediate function have not used RFA or Periotest measurements and clear guidelines how to use these techniques are presently missing.


Q: Isn't there a high risk with immediate function in fresh extraction sites if the extracted tooth was removed because of infection?

A: If the socket is curetted and perfectly cleaned from soft tissue remnants and an adequate stability is reached, the prognosis is likely to be good. However, more clinical documentation is called for at this situation.


Q: In a 3-unit bridge, can an immediately loaded implant be immediately connected to a natural tooth?

A: Probably yes, provided the tooth is stable, but this specific therapy is not clinically documented as yet.



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