J Clin Periodontol. 2012 Feb;39(2):196-202. doi: 10.1111/j.1600-051X.2011.01821.x. Epub 2011 Nov 28.
To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial.
The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment.
Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232).
The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial.
比较无瓣微创条件下即刻与早期非负重种植体在 3 年的平行随机临床试验中的应用。
该研究于 2005 年 7 月至 2010 年 7 月在一家私人牙科诊所进行。18 岁或以上的患者被随机分配接受种植体修复部分缺牙。试验组代表即刻非负重种植体负载,而对照组代表早期非负重种植体负载。主要观察终点为种植体失败、并发症和种植体负荷后 3 年的种植体周围骨吸收。从种植体-基台连接到骨-种植体接触最冠方点的种植体部位进行放射影像学骨吸收测量。随机分组采用计算机生成、密封编号、不透明信封进行分配隐藏,测量者对分组情况设盲。
共 60 名患者随机分组:即刻负载组 30 例,早期负载组 30 例。4 名患者脱落,但所有患者的数据均纳入分析。无种植体失败。对照组发生 2 例并发症,试验组发生 1 例。试验组 3 年时的平均骨吸收水平为 1.91mm,对照组为 1.59mm。调整后的骨吸收差异为 0.26mm(95%CI-0.08 至 0.59,p=0.1232)。
在这项随机临床试验中,不能拒绝即刻或早期负载种植体在 3 年内的失败率、并发症和骨吸收水平无差异的零假设。