Prospective, Multicenter Evaluation of Trabecular Metal‐Enhanced Titanium Dental Implants Placed in Routine Dental Practices: 1‐Year Interim Report From the Development Period (2010 to 2011)

Abstract

BACKGROUND: A prospective, multicenter study is currently evaluating a novel titanium implant with a highly porous tantalum midsection (tantalum material [TM]) placed in an uncontrolled patient population. PURPOSE: Interim 1-year results from the development period (2010-2011) are reported. MATERIALS AND METHODS: Investigators in 22 clinical sites located in five European countries randomly selected and treated partially edentulous patients in accordance with the implant's instructions for use and the investigators' professional judgments. Oversight was provided by the local institutional review boards. Subjects were treated with 1 to 2 TM dental implants in maxillary or mandibular location(s). RESULTS: To date, 105 patients with 57 maxillary and 88 mandibular implants have completed 1 year of clinical monitoring. Within this interim group, 28 patients had concomitant health conditions that may elevate risks for long-term crestal bone loss and/or implant survival. Three implants failed due to local or systemic infection, and four implants failed to integrate. Cumulative implant survival was 95.2% (n = 138/145) with 0.43 ± 0.57 mm of mean marginal bone loss in this interim group. CONCLUSION: TM dental implants were clinically effective under various clinical conditions in an uncontrolled patient population with and without concomitant health conditions.