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结缔组织移植物与异种胶原基质在种植体部位软组织增量中的应用:一项随机对照临床试验。

Connective tissue graft versus xenogeneic collagen matrix for soft tissue augmentation at implant sites: a randomized-controlled clinical trial.

机构信息

Department of Oral Surgery of the Institute of Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), 11 Mozhaisky Val Street, Moscow, 119048, Russian Federation.

Peoples Friendship University of Russia, Moscow, Russian Federation.

出版信息

Clin Oral Investig. 2022 Dec;26(12):7191-7208. doi: 10.1007/s00784-022-04680-x. Epub 2022 Aug 27.

Abstract

OBJECTIVES

The purpose of this randomized clinical trial (RCT) is to compare xenogeneic collagen matrix (XCM) versus subepithelial connective tissue graft (SCTG) to increase soft tissue thickness at implant site.

MATERIALS AND METHODS

The study was a randomized, parallel-group controlled investigation. Thirty patients underwent buccal soft tissue thickness augmentation at the stage of implant placement by two different methods: SCTG (control group) and XCM (test group). Primary outcome was the amount of buccal soft tissue thickness gain, 3 months after the intervention. Secondary outcomes were the operation time, the amount of keratinized mucosa (KM), pain syndrome (PS), and patients' quality of life (QL). Histologic evaluation was also performed.

RESULTS

The amount of soft tissue thickness gain was 1.55±0.11 mm in SCTG group, and 1.18±0.11mm in XCM group. The difference between the SCTG and XCM was -0.366 (-0.66 to -0.07; p=0.016). Operation time with XCM was 8.4 (3.737 to 13.06) min shorter than that with the SCTG (p=0.001). KT, PS, and QL for both groups were not statistically significantly different at any time point (p>0.05). At histological examination, the general picture in both groups was similar. No significant differences between the studied groups in most indices, except for the average and maximum formation thickness, cellularity of the basal, mitotic activity and also maximum length of rete ridges.

CONCLUSION

Within limitations, this study demonstrates that the use of SCTG provides a statistically significant superior soft tissue thickness gain than XCM for soft tissue augmentation procedures around implants.

CLINICAL RELEVANCE

XCM can be used as the method of choice for increasing the thickness of soft tissues.

摘要

目的

本随机临床试验(RCT)旨在比较异种胶原基质(XCM)与黏膜下结缔组织移植(SCTG)在增加种植体部位软组织厚度方面的效果。

材料和方法

该研究为随机、平行对照研究。30 例患者在种植体放置阶段通过两种不同方法(SCTG[对照组]和 XCM[实验组])进行颊侧软组织厚度增加。主要结局为干预 3 个月后的颊侧软组织厚度增加量。次要结局为手术时间、角化黏膜(KM)量、疼痛综合征(PS)和患者生活质量(QL)。还进行了组织学评估。

结果

SCTG 组软组织厚度增加量为 1.55±0.11mm,XCM 组为 1.18±0.11mm。SCTG 组与 XCM 组之间的差异为-0.366(-0.66 至-0.07;p=0.016)。使用 XCM 的手术时间比 SCTG 缩短 8.4(3.737 至 13.06)min(p=0.001)。两组的 KT、PS 和 QL 在任何时间点均无统计学差异(p>0.05)。组织学检查时,两组的总体情况相似。除基底细胞的平均和最大形成厚度、有丝分裂活性以及最大终末乳突长度外,两组之间在大多数指数上无显著差异。

结论

在限制条件下,本研究表明,在种植体周围软组织增加程序中,使用 SCTG 可提供统计学上显著更高的软组织厚度增加效果,优于 XCM。

临床相关性

XCM 可作为增加软组织厚度的首选方法。

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