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牙周微创手术联合和不联合再生材料治疗骨内缺损的疗效:一项随机临床试验。

Efficacy of periodontal minimally invasive surgery with and without regenerative materials for treatment of intrabony defect: a randomized clinical trial.

机构信息

Department of Periodontology, Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, 22 Zhongguancun South Avenue, Haidian District, Beijing, 100081, People's Republic of China.

出版信息

Clin Oral Investig. 2022 Feb;26(2):1613-1623. doi: 10.1007/s00784-021-04134-w. Epub 2021 Aug 20.

Abstract

OBJECTIVES

The minimally invasive surgical technique was modified in suture (MISTms) in this study. The trial was to determine the efficacy of MISTms with and without regenerative materials for the treatment of intrabony defect and to identify factors influencing 1-year clinical attachment level (CAL) gain.

METHODS

Thirty-six patients with interdental intrabony defects were randomly assigned to MISTms (MISTms alone, 18) or MISTms plus deproteinized bovine bone mineral and collagen membrane (MISTms combined, 18). Wound healing was evaluated by early healing index (EHI) at 1, 2, 3, and 6 weeks. Probing depth (PD), CAL, gingival recession, radiographic defect depth, and distance from the base of defect to the cementoenamel junction were recorded at baseline and 1 year postoperatively. A one-year composite outcome measure based on the combination of CAL gain and post-surgery PD was evaluated. Factors influencing 1-year CAL gain were analyzed.

RESULTS

Fifteen patients in MISTms-alone and 16 in the MISTms-combined group finished the study. The MISTms-alone group showed significantly better wound healing at 1 week. CAL significantly gained in the MISTms-alone and MISTms-combined group, with 2.53 ± 1.80 mm and 2.00 ± 1.38 mm respectively. The radiographic bone gain was 3.00 ± 1.56 mm and 3.85 ± 1.69 mm respectively. However, there were no significant differences between the two groups about 1-year outcomes. Lower EHI (optimal wound healing) and more baseline CAL positively influenced 1-year CAL gain.

CONCLUSIONS

MISTms is an effective treatment for intrabony defects. The regenerative materials do not show an additional effect on 1-year outcomes. Early wound healing and baseline CAL are factors influencing 1-year CAL gain.

CLINICAL RELEVANCE

MISTms with and without regenerative materials are both effective treatments for intrabony defect.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: ChiCTR2100043272.

摘要

目的

本研究对微创外科技术(MISTms)进行了改良。该试验旨在确定 MISTms 联合和不联合再生材料治疗骨内缺损的疗效,并确定影响 1 年临床附着水平(CAL)增加的因素。

方法

将 36 例牙周骨内缺损患者随机分为 MISTms 组(MISTms 单独治疗,18 例)或 MISTms 联合组(MISTms 联合使用脱蛋白牛骨矿物质和胶原膜,18 例)。通过 1、2、3 和 6 周时的早期愈合指数(EHI)评估伤口愈合情况。在基线和术后 1 年记录探诊深度(PD)、CAL、牙龈退缩、放射状骨缺损深度和从缺损底部到牙骨质界的距离。基于 CAL 增加和术后 PD 的组合,评估 1 年的综合结果测量指标。分析影响 1 年 CAL 增加的因素。

结果

MISTms 单独治疗组 15 例患者和 MISTms 联合治疗组 16 例患者完成了研究。MISTms 单独治疗组在第 1 周时的伤口愈合情况明显更好。MISTms 单独治疗组和 MISTms 联合治疗组的 CAL 均显著增加,分别为 2.53±1.80mm 和 2.00±1.38mm。放射状骨增量分别为 3.00±1.56mm 和 3.85±1.69mm。然而,两组在 1 年的结果方面没有显著差异。较低的 EHI(最佳伤口愈合)和较高的基线 CAL 对 1 年 CAL 增加有积极影响。

结论

MISTms 是治疗骨内缺损的有效方法。再生材料对 1 年的结果没有额外的影响。早期的伤口愈合和基线 CAL 是影响 1 年 CAL 增加的因素。

临床相关性

MISTms 联合和不联合再生材料治疗骨内缺损均有效。

试验注册

临床试验.gov 标识符:ChiCTR2100043272。

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