Quirynen Marc, Al-Nawas Bilal, Meijer Henny J A, Razavi Amir, Reichert Torsten E, Schimmel Martin, Storelli Stefano, Romeo Eugenio
Catholic University Leuven, Leuven, Belgium.
Johannes-Gutenberg University, Mainz, Germany.
Clin Oral Implants Res. 2015 Jul;26(7):831-40. doi: 10.1111/clr.12367. Epub 2014 Apr 9.
The aim of this study was to compare crestal bone-level changes, soft tissue parameters and implant success and survival between small-diameter implants made of titanium/zirconium (TiZr) alloy or of Grade IV titanium (Ti) in edentulous mandibles restored with removable overdentures.
This was a randomized, controlled, double-blind, split-mouth multicenter clinical trial. Patients with edentulous mandibles received two Straumann bone-level implants (diameter 3.3 mm), one of Ti Grade IV (control) and one of TiZr (test), in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 months.
Of 91 treated patients, 75 completed the three-year follow-up. Three implants were lost (two control and one test implant). The survival rates were 98.7% and 97.3%, and the mean marginal bone level change was -0.78 ± 0.75 and -0.60 ± 0.71 mm for TiZr and Ti Grade IV implants. Most patients had a plaque score of 0 or 1 (54% for test and 51.7% for control), and a sulcus bleeding score of 0 (46.1% for test and 44.9% for control). No significant differences were found between the two implant types for bone-level change, soft tissue parameters, survival and success.
After 36 months, similar outcomes were found between Ti Grade IV and TiZr implants. The results confirm that the results seen at 12 months continue over time.
本研究旨在比较钛锆（TiZr）合金或IV级钛（Ti）制成的小直径种植体在采用可摘覆盖义齿修复的无牙下颌骨中，牙槽嵴骨水平变化、软组织参数以及种植体的成功率和存留率。
这是一项随机、对照、双盲、分口多中心临床试验。无牙下颌骨患者在双侧孔间区域植入两枚士卓曼骨水平种植体（直径3.3 mm），一枚为IV级钛种植体（对照），一枚为TiZr种植体（试验）。种植体在6 - 8周后加载，并在加载后2周内佩戴可摘Locator附着式覆盖义齿。评估至36个月时的改良菌斑和龈沟出血指数、影像学骨水平以及种植体的存留率和成功率。
91例接受治疗的患者中，75例完成了三年随访。有3枚种植体脱落（2枚对照种植体和1枚试验种植体）。TiZr种植体和IV级钛种植体的存留率分别为98.7%和97.3%，平均边缘骨水平变化分别为-0.78±0.75和-0.60±0.71 mm。大多数患者的菌斑评分为0或1（试验组为54%，对照组为51.7%），龈沟出血评分为0（试验组为46.1%，对照组为44.9%）。两种种植体在骨水平变化、软组织参数、存留率和成功率方面均未发现显著差异。
36个月后，IV级钛种植体和TiZr种植体的结果相似。结果证实12个月时观察到的结果随时间持续存在。
