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膜稳定化对牙周受损拔牙窝牙槽嵴保存的影响:一项非劣效性随机对照试验

The Impact of Membrane Stabilization for Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets: A Non-Inferiority Randomized Controlled Trial.

作者信息

Lee Seung-Ju, Lee Jungwon, Suh Hyemee, Ko Young-Chang, Urban Istvan, Koo Ki-Tae

机构信息

Department of Periodontology and Dental Research Institute, School of Dentistry, Seoul National University, Seoul, Republic of Korea.

One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul, Republic of Korea.

出版信息

J Clin Periodontol. 2025 Mar;52(3):471-483. doi: 10.1111/jcpe.14092. Epub 2024 Dec 10.

Abstract

AIM

The aim of this study was to investigate the non-inferiority of alveolar ridge preservation (ARP) with membrane stabilization compared with non-stabilization, focusing on changes of soft-tissue contour in periodontally compromised extraction sockets. Secondary outcomes included changes in hard-tissue contour, patient-reported outcomes and new bone formation.

MATERIALS AND METHODS

Twenty-four patients with periodontally compromised teeth were randomly assigned to ARP with (test group) or without (control group) membrane stabilization. To assess profilometric and hard-tissue dimensional changes, dental impressions and cone beam computed tomography scans were performed at baseline (T0), immediately after ARP (T1) and 4 months post surgery (T2). Soft-tissue healing in open healing sites was evaluated at T2, and wound closure was assessed 10 days post surgery. Patient-reported outcomes were documented, and core biopsies were obtained for histomorphometric analysis.

RESULTS

The absolute profilometric horizontal width change at 3 mm below the crest in the test group was not inferior to that in the control group. For the relative values, horizontal width reduction (3 and 5 mm below the crest) and volumetric shrinkage (3-5 mm below the crest) were lower in the test group. No significant differences were observed in bone dimensional changes, wound healing, pain and swelling or histomorphometric outcomes.

CONCLUSION

ARP with membrane stabilization in periodontally compromised extraction sockets is non-inferior in terms of soft-tissue contour changes to those without membrane fixation.

TRIAL REGISTRATION

Clinical Research Information Service (CRIS), KCT0005280. Registered 4 August 2020, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=19165&search_page=L.

摘要

目的

本研究旨在探讨与不使用膜稳定化技术相比,使用膜稳定化技术进行牙槽嵴保存(ARP)的非劣效性,重点关注牙周受损拔牙窝软组织轮廓的变化。次要结果包括硬组织轮廓的变化、患者报告的结果和新骨形成。

材料与方法

24例牙周受损牙齿患者被随机分为使用(试验组)或不使用(对照组)膜稳定化技术的ARP组。为评估轮廓测量和硬组织尺寸变化,在基线(T0)、ARP后即刻(T1)和术后4个月(T2)进行牙印模和锥形束计算机断层扫描。在T2评估开放愈合部位的软组织愈合情况,并在术后10天评估伤口闭合情况。记录患者报告的结果,并获取核心活检组织进行组织形态计量分析。

结果

试验组在牙槽嵴顶下方3mm处的绝对轮廓测量水平宽度变化不劣于对照组。对于相对值,试验组在牙槽嵴顶下方3mm和5mm处的水平宽度减小以及体积缩小较低。在骨尺寸变化、伤口愈合、疼痛和肿胀或组织形态计量结果方面未观察到显著差异。

结论

在牙周受损拔牙窝中,使用膜稳定化技术的ARP在软组织轮廓变化方面不劣于不使用膜固定的情况。

试验注册

临床研究信息服务(CRIS),KCT0005280。2020年8月4日注册,https://cris.nih.go.kr/cris/search/detailSearch.do?seq=19165&search_page=L。

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