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部分牙列缺损患者牙种植体即刻非咬合负重与早期负重:一项多中心随机对照临床试验的1年结果

Immediate nonocclusal versus early loading of dental implants in partially edentulous patients: 1-year results from a multicenter, randomized controlled clinical trial.

作者信息

Testori Tiziano, Galli Fabio, Capelli Matteo, Zuffetti Francesco, Esposito Marco

机构信息

Section of Implantology and Oral Rehabilitation, Department of Odontology, Galeazzi Institute, University of Milan, Italy.

出版信息

Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):815-22.

Abstract

PURPOSE

To compare the efficacy of immediate nonocclusal loading (test group) versus early loading (control group) in partially edentulous patients.

MATERIALS AND METHODS

Fifty-two patients in 5 Italian private practices were randomized to 1 of the treatments: 25 to the immediately loaded group and 27 to the early loaded group. To be immediately loaded, single implants had to be inserted with a torque of > 30 Ncm, and splinted implants had to be inserted with a torque of > 20 Ncm. Implants in the immediately loaded group were provided with full acrylic resin nonoccluding temporary restorations within 48 hours after placement. After 2 months, full occluding provisional restorations were provided. Implants in the early loading group were not submerged and were loaded after 2 months. At 8 months, provisional restorations were replaced with definitive metal-ceramic prostheses. Outcome measures were prosthesis and implant failures as well as biologic and prosthetic complications recorded by nonblinded assessors. The Fisher exact test was used to compare the proportion of implant failures.

RESULTS

Fifty-two implants were placed in the immediately loaded group and 52 in the early loaded group. No dropouts or complications occurred up to 14 months postinsertion. One single implant failed in the immediately loaded group 2 months after placement. There was no statistically difference for the tested outcome measures between the 2 procedures (P > .99).

CONCLUSIONS

The results of this randomized controlled clinical trial with 25 patients rehabilitated with immediately restored nonocclusally loaded implant-supported prostheses compared to 27 patients restored 2 months following placement suggest that there are no major clinical differences in implant survival between these 2 protocols. No biologic or prosthetic complications occurred.

摘要

目的

比较部分牙列缺损患者即刻非咬合负重(试验组)与早期负重(对照组)的疗效。

材料与方法

意大利5家私人诊所的52例患者被随机分为两种治疗组之一:25例进入即刻负重组,27例进入早期负重组。对于即刻负重,单个种植体植入时扭矩须>30 Ncm,联合种植体植入时扭矩须>20 Ncm。即刻负重组的种植体在植入后48小时内安装全丙烯酸树脂非咬合临时修复体。2个月后,安装全咬合临时修复体。早期负重组的种植体不进行埋入式处理,在2个月后进行负重。8个月时,将临时修复体更换为最终的金属烤瓷修复体。观察指标为修复体和种植体失败情况,以及由非盲法评估者记录的生物学和修复并发症。采用Fisher精确检验比较种植体失败的比例。

结果

即刻负重组植入52枚种植体,早期负重组植入52枚种植体。植入后14个月内未出现失访或并发症。即刻负重组有1枚单个种植体在植入后2个月失败。两种方法在观察指标上无统计学差异(P>.99)。

结论

本随机对照临床试验结果显示,25例患者采用即刻恢复非咬合负重的种植体支持修复体进行修复,27例患者在植入2个月后进行修复,这两种方案在种植体存留率方面无重大临床差异。未发生生物学或修复并发症。

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