Title: 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
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 #
Issue Date: Dec-2012
Series Title: Clinical Implant Dentistry and Related Research vol:14 issue:6 pages:896-904
Article number: 10.1111/j.1708-8208.2010.00324.x
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.
ISSN: 1523-0899
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Periodontology
× corresponding author
# (joint) last author

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