Markus Schlee1, Guillermo Pradies2,3, Wolf-Ullrich Mehmke4, Arnaud Beneytout5, Matthais Stamm6, Ramón Gómez Meda7, Torsten Kamm8, Francois Poiroux9, Franz Weinlich10, Mariano del Canto Pingarron11, Eric Crichton12, Jean-Baptiste Poulet13, Philippe Bousquet14. 1. Private Practice in Periodontology and Oral Implantology, Forcheim, Germany. 2. Faculty of Dentistry, Complutense University, Madrid, Spain. 3. Private Practice in Prosthodontics and Oral Implantology, Madrid, Spain. 4. Private Practice in Periodontology and Oral Implantology, Chemnitz, Germany. 5. Private Practice in Oral Surgery, Periodontology, and Oral Implantology, Bordeaux, France. 6. Private Practice in Oral Implantology and Periodontology, Overath, Germany. 7. Private Practice in Oral Surgery, Ponferrada, Leon, Spain. 8. Private Practice in Esthetic Dentistry, Periodontology, and Oral Implantology, Baden-Baden, Germany. 9. Private Practice in Periodontology and Oral Implantology, La Rochelle, France. 10. Private Practice in General Dentistry and Oral Implantology, Neu-Isenburg, Germany. 11. Oral Surgery, Implantology and Periodontology, University of Léon, Leon, Spain. 12. Private Practice in Periodontology and Oral Implantology, Houilles, France. 13. Private Practice in Oral Implantology, Tarare, France. 14. Periodontology and Implantology, Montpellier University, Béziers, France.
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.
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 edentulouspatients 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.