A Double-Blind Randomized Controlled Trial (RCT) of Titanium-13Zirconium versus Titanium Grade IV Small-Diameter Bone Level Implants in Edentulous Mandibles - Results from a 1-Year Observation Period |
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| Authors: | Al-Nawas Bilal Brägger Urs Meijer Henny J A Naert Ignace Persson Rigmor Perucchi Alessandro Quirynen Marc Raghoebar Gerry M Reichert Torsten E Romeo Eugenio Santing Hendrik J Schimmel Martin Storelli Stefano Bruggenkate Christiaan Ten Vandekerckhove Betty Wagner Wilfried Wismeijer Daniel Müller Frauke |
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| Institution: | Professor, Johannes-Gutenberg University, Mainz, Germany; professor, University of Bern, School of Dental Medicine, Bern, Switzerland; professor, Departments of Oral-Maxillofacial Surgery and Prosthetic Dentistry, University Medical Center Groningen, Groningen, The Netherlands; professor, Catholic University Leuven, School of Dentistry, Leuven, Belgium; doctor, University of Bern, School of Dental Medicine, Bern, Switzerland; doctor, Luzerner Kantonsspital Clinic for Oral and Maxillofacial Surgery, Lucerne, Switzerland; professor, Catholic University Leuven, School of Dentistry, Leuven, Belgium; professor, Departments of Oral-Maxillofacial Surgery and Prosthetic Dentistry, University Medical Center Groningen, Groningen, The Netherlands; professor, University of Regensburg Clinic, Regensburg, Germany; professor, University of Milan, Dental Clinic, San Paolo Hospital, Milan, Italy; doctor, Departments of Oral-Maxillofacial Surgery and Prosthetic Dentistry, University Medical Center Groningen, Groningen, The Netherlands; doctor, University of Geneva, Division of Gerodontology and Removable Prosthodontics, Geneva, Switzerland; doctor, University of Milan, Dental Clinic, San Paolo Hospital, Milan, Italy; professor, Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands; doctor, Catholic University Leuven, School of Dentistry, Leuven, Belgium; professor, Johannes-Gutenberg University, Mainz, Germany; professor, Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands; professor, University of Geneva, Division of Gerodontology and Removable Prosthodontics, Geneva, Switzerland. |
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| Abstract: | Background: The use of endosseous dental implants has become common practice for the rehabilitation of edentulous patients, and a two‐implant overdenture has been recommended as the standard of care. The use of small‐diameter implants may extend treatment options and reduce the necessity for bone augmentation. However, the mechanical strength of titanium is limited, so titanium alloys with greater tensile and fatigue strength may be preferable. Purpose: This randomized, controlled, double‐blind, multicenter study investigated in a split‐mouth model whether small‐diameter implants made from Titanium‐13Zirconium alloy (TiZr, Roxolid?) perform at least as well as Titanium Grade IV implants. Methods and Materials: Patients with an edentulous mandible received one TiZr and one Ti Grade IV small‐diameter bone level implant (3.3 mm, SLActive®) in the interforaminal region. The site distribution was randomized and double‐blinded. Outcome measures included change in radiological peri‐implant bone level from surgery to 12 months post‐insertion (primary), implant survival, success, soft tissue conditions, and safety (secondary). Results: Of 91 treated patients, 87 were available for the 12‐month follow‐up. Peri‐implant bone level change (?0.3 ± 0.5 mm vs ?0.3 ± 0.6 mm), plaque, and sulcus bleeding indices were not significantly different between TiZr and Ti Grade IV implants. Implant survival rates were 98.9 percent and 97.8 percent, success rates were 96.6 percent and 94.4 percent, respectively. Nineteen minor and no serious adverse events were related to the study devices. Conclusion: This study confirms that TiZr small‐diameter bone level implants provide at least the same outcomes after 12 months as Ti Grade IV bone level implants. The improved mechanical properties of TiZr implants may extend implant therapy to more challenging clinical situations. |
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| Keywords: | alloy bone level implant double‐blind edentulous mandible Locator RCT Titanium Zirconium |
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