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上颌窦外侧壁提升术的一期与二期手术:一项多中心随机对照试验的加载后4个月结果

1-stage versus 2-stage lateral maxillary sinus lift procedures: 4-month post-loading results of a multicenter randomised controlled trial.

作者信息

Felice Pietro, Pistilli Roberto, Piattelli Maurizio, Soardi Elisa, Pellegrino Gerardo, Corvino Valeria, Esposito Marco

机构信息

Department of Periodontology and Implantology, University of Bologna, Bologna, Italy.

出版信息

Eur J Oral Implantol. 2013 Summer;6(2):153-65.

Abstract

PURPOSE

To compare the efficacy of 1-stage versus 2-stage lateral maxillary sinus lift procedures.

MATERIALS AND METHODS

Sixty partially edentulous patients requiring 1 to 3 implants and having 1 to 3 mm of residual bone height and at least 5 mm of bone width below the maxillary sinus, as measured on CT scans, were randomised into two equal groups to receive either a 1-stage lateral window sinus lift with simultaneous implant placement or a 2-stage procedure with implant placement delayed by 4 months using a bone substitute in 3 different centres. Implants were submerged for 4 months and loaded with reinforced provisional prostheses, which were replaced, after 4 months, by definitive prostheses. Outcome measures were augmentation procedure failures, prosthesis failures, implant failures, complications and marginal peri-implant bone loss assessed by a blinded outcome assessor. Patients were followed up to 4 months after loading. Only data of implants placed in 1 to 3 mm of bone height were reported.

RESULTS

Two patients dropped out from the 1-stage group and none from the 2-stage group. No sinus lift procedure failed in the 1-stage group but 1 failed in the 2-stage group, the difference was not statistically significant (P = 1.00). Two prostheses failed or could not be placed in the planned time in the 1-stage group and 1 in the 2-stage group, the difference was not statistically significant (P = 0.51). Three implants failed in 3 patients of the 1-stage group versus 1 implant in the 2-stage group, the difference was not statistically significant (P = 0.28). Two complications occurred in the 1-stage group and 1 in the 2-stage group, the difference was not statistically significant (P = 0.61). There were no statistically significant differences in bone loss between groups at loading (0.05 mm). Sites treated in 1 stage lost an average of 0.56 mm (SD: 0.36; 95% CI: -0.70 to -0.42; P < 0.001) of peri-implant bone and 2-stage sites approximately 0.61 mm (SD: 0.34; 95% CI: -0.74 to -0.48; P < 0.001).

CONCLUSIONS

No statistically significant differences were observed between implants placed according to 1- or 2-stage sinus lift procedures. However, this study may suggest that in patients having a residual bone height between 1 and 3 mm below the maxillary sinus there might be a slightly higher risk for implant failures when performing a 1-stage lateral sinus lift procedure.

摘要

目的

比较上颌窦外侧壁提升一期手术与二期手术的疗效。

材料与方法

60例部分牙列缺失患者,需要植入1至3颗种植体,根据CT扫描测量,上颌窦下方剩余骨高度为1至3毫米,骨宽度至少为5毫米。这些患者被随机分为两组,在3个不同中心分别接受一期外侧开窗上颌窦提升并同期植入种植体,或二期手术,使用骨替代材料,种植体植入延迟4个月。种植体埋入4个月后,安装加强型临时修复体,4个月后更换为最终修复体。观察指标包括上颌窦提升手术失败、修复体失败、种植体失败、并发症以及由盲法结果评估者评估的种植体周围边缘骨丢失。患者在加载后随访至4个月。仅报告植入骨高度为1至3毫米的种植体的数据。

结果

一期组有2例患者退出,二期组无患者退出。一期组上颌窦提升手术均未失败,二期组有1例失败,差异无统计学意义(P = 1.00)。一期组有2个修复体失败或未能在计划时间内安装,二期组有1个,差异无统计学意义(P = 0.51)。一期组3例患者的3颗种植体失败,二期组1颗种植体失败,差异无统计学意义(P = 0.28)。一期组发生2例并发症,二期组发生1例,差异无统计学意义(P = 0.61)。加载时两组间骨丢失无统计学差异(0.05毫米)。一期治疗部位种植体周围骨平均丢失0.56毫米(标准差:0.36;95%置信区间:-0.70至-0.42;P < 0.001),二期治疗部位约为0.61毫米(标准差:0.34;95%置信区间:-0.74至-0.48;P < 0.001)。

结论

根据一期或二期上颌窦提升手术植入的种植体之间未观察到统计学上的显著差异。然而,本研究可能表明,在上颌窦下方剩余骨高度为1至3毫米的患者中,进行一期外侧上颌窦提升手术时种植体失败的风险可能略高。

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