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口腔种植学中骨增量手术中膜的临床价值:随机对照试验的系统评价

The clinical value of membranes in bone augmentation procedures in oral implantology: 
A systematic review of randomised controlled trials.

作者信息

Jonker Brend P, Roeloffs Maarten W K, Wolvius Eppo B, Pijpe Justin

出版信息

Eur J Oral Implantol. 2016;9(4):335-365.

PMID:27990504
Abstract

PURPOSE

To determine the clinical value of membranes in bone augmentation procedures such as ridge augmentation with simultaneous (one-stage) and delayed (two-stage) implant placement, sinus augmentation surgery, ridge preservation and immediate implant placement.

MATERIALS AND METHODS

In April 2016, Embase, Medline (Ovid-SP), Cochrane Central, Web of Science and PubMed (as supplied by the publisher) were searched. There were no restrictions regarding language or publication date. Randomised controlled trials that reported membranes in bone augmentation procedures with a minimum follow-up period of 6 months after implant loading or that described geometrical changes of the bone graft at re-entry were included. Membrane placement had to be the only variable in the procedure. Outcomes were implant failure, complications, horizontal bone gain and resorption, graft resorption, defect height reduction, marginal bone loss around implants, aesthetic results and patient satisfaction. The results were pooled using fixed-effect models with mean differences (MDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes.

RESULTS

After screening the titles and abstracts of 1843 papers, 32 potentially eligible articles were selected. Seventeen articles involving 10 trials were included in this review. These studies presented outcome data for 355 patients. Seven trials were considered to be at a high risk of bias, two at a low risk of bias and one at an unclear risk of bias. Insufficient evidence was found to determine whether there were differences in implant failure rates, marginal bone level changes, aesthetic results or patient satisfaction. For one-stage ridge augmentation (two trials; n = 52), there was evidence of more horizontal bone gain (MD: 0.84 mm, 95% CI: 0.46 to 1.21, P < 0.00001; two trials), defect height reduction (MD: 18.36%, 95% CI: 10.23 to 26.50, P < 0.00001; two trials), and prevention of graft resorption (P = 0.004; one trial) in favour of the membrane-covered group, although substantial heterogeneity was found for horizontal bone gain (Chi2; P = 0.05, I2=74%). There was insufficient evidence to determine whether any differences exist in two-stage ridge augmentation (three trials; n = 81), sinus augmentation (one trial; n = 104) and ridge preservation (one trial; n = 20). For immediate implant placement (three trials; n = 98), there was evidence of an increased defect height reduction in favour of the membrane-covered groups (MD: 6.25%, 95% CI: 1.67 to 10.82, P = 0.007; two trials), although with substantial heterogeneity (Chi2; P = 0.03, I2 = 79%). More complications were observed when a membrane was used (OR: 2.52, 95% CI: 1.07 to 5.93, P = 0.03; three trials).

CONCLUSIONS

There is insufficient evidence regarding the effects of membranes on bone augmentation procedures to support any definitive conclusions. Only 10 studies were included; they had limited sample sizes and short follow-up periods, and the majority were at a high risk of bias. However, no difference in implant failure was found, and the possible clinical value is still unknown, as long-term clinical parameters such as marginal bone loss, aesthetic results and patient satisfaction have been insufficiently studied. Conflict-of-interest and source-of-funding statement: The authors declare that they have no possible conflicts of interest. No funding for this review was received.

摘要

目的

确定屏障膜在骨增量手术中的临床价值,如同时(一期)和延期(二期)种植体植入的牙槽嵴增高术、上颌窦提升术、牙槽嵴保存术以及即刻种植体植入术。

材料与方法

2016年4月,检索了Embase、Medline(Ovid-SP)、Cochrane中心、科学引文索引和PubMed(由出版商提供)。对语言和出版日期无限制。纳入报告了骨增量手术中屏障膜且种植体加载后至少随访6个月或描述了再次切开时骨移植几何变化的随机对照试验。屏障膜的放置必须是该手术中的唯一变量。观察指标包括种植体失败、并发症、水平骨增量和吸收、移植骨吸收、缺损高度降低、种植体周围边缘骨丢失、美学效果和患者满意度。使用固定效应模型汇总结果,连续变量采用均数差(MDs),二分变量采用比值比(ORs)。

结果

在筛选了1843篇论文的标题和摘要后,选择了32篇可能符合条件的文章。本综述纳入了17篇涉及10项试验的文章。这些研究提供了355例患者的结果数据。7项试验被认为存在高偏倚风险,2项试验存在低偏倚风险,1项试验的偏倚风险不明确。没有足够的证据来确定种植体失败率、边缘骨水平变化、美学效果或患者满意度是否存在差异。对于一期牙槽嵴增高术(两项试验;n = 52),有证据表明屏障膜覆盖组水平骨增量更多(MD:0.84 mm,95%CI:0.46至1.21,P < 0.00001;两项试验)、缺损高度降低(MD:18.36%,95%CI:10.23至26.50,P < 0.00001;两项试验)以及预防移植骨吸收(P = 0.004;一项试验),尽管水平骨增量存在显著异质性(Chi2;P = 0.05,I2 = 74%)。没有足够的证据来确定在二期牙槽嵴增高术(三项试验;n = 81)、上颌窦提升术(一项试验;n = 104)和牙槽嵴保存术(一项试验;n = 20)中是否存在差异。对于即刻种植体植入术(三项试验;n = 98),有证据表明屏障膜覆盖组缺损高度降低更多(MD:6.25%,95%CI:1.67至10.82,P = 0.007;两项试验),尽管存在显著异质性(Chi2;P = 0.03,I2 = 79%)。使用屏障膜时观察到更多并发症(OR:2.52,95%CI:1.07至5.93,P = 0.03;三项试验)。

结论

关于屏障膜对骨增量手术影响的证据不足,无法支持任何确定性结论。仅纳入了10项研究;样本量有限且随访期短,大多数研究存在高偏倚风险。然而,未发现种植体失败存在差异,且由于边缘骨丢失、美学效果和患者满意度等长期临床参数研究不足,其可能的临床价值仍未知。利益冲突和资金来源声明:作者声明他们不存在任何可能的利益冲突。本综述未获得资金支持。

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