NobelDirect: Efficacy Reconfirmed?

Nobel DirectThis past Monday the Sweden’s Medical Products Agency (MPA) demanded that Nobel Biocare further improve instructions for use of NobelDirect(tm) and NobelPerfect(tm) one-piece dental implants. The MPA told the firm in late 2006 to improve product information on the NobelDirect and NobelPerfect implants after a probe revealed possible shortcomings in instructions that could explain a breakdown of the jawbone in some patients.

“The Medical Products Agency has now reviewed the company’s plan for improvement of the information on the dental implants and takes the decision that the information must be supplemented and further clarified,” the MPA said in a statement.

In reacting to the MPA announcement, Nobel Biocare stated:

“Nobel Biocare welcomes the renewed confirmation of market clearance without constraints by the MPA for NobelDirect(tm) and NobelPerfect(tm) one-piece implants. The comprehensive scientific evidence that Nobel Biocare provided to the MPA proved the product safety and effectiveness of NobelDirect(tm) and NobelPerfect(tm) one-piece implants. The prospective multi-center study and additional extensive scientific documentation representing 1973 implants followed up to six years have led the MPA to reconfirm their decisions of February 2006 and December 2006 and to reiterate the market clearance for both products. The Company is pleased that a conclusion was found after a 19-month process….The allegations against the products have been fully refuted.”

But will the revised instructions and warning notices on the NobelDirect and NobelPerfect implants dampen future enthusiasm for these implants? Is this truly the end of this saga for Nobel with NobelDirect? What are your thoughts?

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Comments

3 Responses to “NobelDirect: Efficacy Reconfirmed?”

  1. steve c on June 27th, 2007 5:38 pm

    I’ve used Nobel Direct successfully since they were introduced several years ago. They are definitely not intended for all areas of the mouth but the 3.0 mm is useful in the lower anterior and for the occasional upper lateral incisor site. My success rate and satisfaction with one piece implants is the same as with any two piece system I’ve used.

  2. Gerald Niznick on June 27th, 2007 11:51 pm

    Sure Nobel oversold the simplicity of the implant with “guarantees” of success that were unsubstantiated, but there is no reason why a one-piece implant should be subject to any more failure or bone loss than a two-piece implant that has an abutment attached immediately following insertion. The exception to this may be the NobelDirect design because it does not have a defined margin (other than their “Posterior Direct” Implant. With TiUnite running up to the top of the abutment, extensive intra-oral preparation is needed which is not a good idea to do immediately following implant insertion. If it were a two-piece implant used for immediate load, the abutment would be prepared out of the mouth before attachment. As for the NobelPerfect implant, since no one ever seriously used it, in part because it cost $650, whatever they say on the label will not matter.

  3. steve c on July 8th, 2007 2:59 pm

    The cost of Nobel Direct is about the same as the cost of Replace Select plus a permanent abutment and there is no need for a healing abutment.

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