Survival of NobelDirect implants:: An analysis of 550 consecutively placed implants at 18 different clinical centers

Background: A recently introduced implant, the NobelDirect (Nobel Biocare AB, Goteborg, Sweden), has previously been documented with substantial bone resorption in a large number of operated cases. Purpose: The aim of this study was to evaluate the failure rate of NobelDirect implants in a retrospective multicenter survey. Materials and Methods: A total of 550 NobelDirect implants consecutively placed in over 269 patients at 18 centers were evaluated with regard to failure rate after an average follow-up of about 1 year. Results: The overall failure percentage was 10.9% (59 failures). The 58 implants not loaded directly showed only one failure (1.7%) versus 58 failures (11.8%) of those implants that were loaded directly. A chemical x-ray photoelectron spectroscopy analysis of an implant from the original batch showed up to 3.5% silicon at parts of the implants. A retrieval analysis of one implant removed at 2 years after placement demonstrated bone resorption down to the level of the fifth thread. Conclusions: It is concluded that the NobelDirect implant, if placed with a punch procedure, ground down in situ, and loaded directly, shows an unusually high failure rate at 1 year.