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无瓣微创技术即刻与早期非负重种植体在部分牙缺失患者中的 10 年随机临床试验

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: A 10-year randomized clinical trial.

机构信息

Clinica Merli, Rimini, Italy.

University Politecnica delle Marche, Ancona, Italy.

出版信息

J Clin Periodontol. 2020 May;47(5):621-629. doi: 10.1111/jcpe.13279. Epub 2020 Mar 24.

Abstract

AIM

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 10-year, parallel group, randomized clinical trial.

MATERIALS AND METHODS

Patients were randomized to receive implants for fixed partial dentures. The immediate group was represented by immediate non-occlusal implant loading, whereas the early group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications, subjective satisfaction and radiographic bone level at implant sites 10 years after loading.

RESULTS

Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Three patients dropped out in the immediate group, and three patients dropped out in the early group. One implant failure occurred in the early group (p = 1.0). Three complications occurred in the immediate group and four in the early group (RR = 0.75, 95% CI 0.19 to 3.04, p = 1.0). The difference in bone level was 0.1 mm (95% CI -0.2 to 0.5, p = .3752) favouring the early group. Difference in subjective functional satisfaction was 0.2 (95% CI -0.2 to 0.7; p = .3271). Difference in subjective aesthetic satisfaction was 0.0 (95% CI -0.4 to 0.4; p = .9656).

CONCLUSION

At 10-year follow-up, no differences between implants loaded immediately and early were detected in this randomized clinical trial.

摘要

目的

比较无瓣微创条件下即刻与早期非负重种植体的 10 年临床随机对照研究。

材料与方法

患者随机接受用于固定局部义齿的种植体。即刻组为即刻非负重种植体加载,早期组为早期非负重种植体加载。主要结局变量为种植体失败、并发症、主观满意度和种植体植入部位的放射影像学骨水平。

结果

60 例患者随机分组:即刻加载组 30 例,早期加载组 30 例。即刻加载组中有 3 例患者脱落,早期加载组中有 3 例患者脱落。早期加载组发生 1 例种植体失败(p=1.0)。即刻加载组发生 3 例并发症,早期加载组发生 4 例并发症(RR=0.75,95%CI 0.19 至 3.04,p=1.0)。骨水平差异为 0.1mm(95%CI-0.2 至 0.5,p=0.3752),早期加载组更有优势。主观功能满意度差异为 0.2(95%CI-0.2 至 0.7;p=0.3271)。主观美学满意度差异为 0.0(95%CI-0.4 至 0.4;p=0.9656)。

结论

在 10 年随访中,本随机临床试验未发现即刻与早期负重种植体之间存在差异。

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