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
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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DOI：
10.1111/j.1708-8208.2010.00324.x
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发表时间：
2012-12-01
影响因子：
3.6
通讯作者：
Mueller, Frauke
中科院分区：
文献类型：
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作者：
Al-Nawas, Bilal;Bragger, Urs;Mueller, Frauke
背景资料：使用骨内牙种植体已成为无牙颌患者康复的常见做法，双种植体覆盖义齿已被推荐为护理标准。使用小直径种植体可以扩大治疗选择，减少骨增量的必要性。目的：本研究采用随机、对照、双盲、多中心的方法，在裂口模型上研究了钛-13锆合金制成的小直径种植体在种植体植入后，其抗拉强度和抗疲劳强度的变化，以及种植体的抗拉强度和抗疲劳强度的变化。（TiZr，Roxolid（TM））的性能至少与IV级钛植入物一样好。下颌无牙患者在椎间孔区域植入一个钛锆和一个钛IV级小直径骨水平种植体（3.3 mm，SLActive（R））。研究中心分布为随机化和双盲。结果指标包括从手术到插入后12个月（主要），种植体存活率，成功率，软组织状况和安全性（次要）的放射学种植体周围骨水平的变化。TiZr和Ti IV级种植体之间的种植体周围骨水平变化（-0.3 +/- 0.5 mm vs -0.3 +/- 0.6 mm）、斑块和龈沟出血指数无显著差异。种植体存活率分别为98.9%和97.8%，成功率分别为96.6%和94.4%。19个轻微的和没有严重的不良事件与研究devices.Conclusion：这项研究证实，钛锆小直径骨水平植入物提供至少相同的结果后，12个月的钛IV级骨水平植入物。钛锆种植体的机械性能的改善可能会将种植体治疗扩展到更具挑战性的临床情况。
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 (TM)) 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 (R)) 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.