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胶原蛋白基质与结缔组织移植用于种植体周围软组织增量的三维分析:一项随机对照试验

3D-Analysis of Peri-Implant Soft Tissue Gain With Collagen Matrix and Connective Tissue Graft: A Randomized Control Trial.

作者信息

Ashurko Igor, Tarasenko Svetlana, Magdalyanova Mary, Balyasin Maxim, Galyas Anna, Kazumyan Sabina, Safi Nadiya, Unkovskiy Alexey

机构信息

Department of Dental Surgery, Sechenov First Moscow State Medical University, Moscow, Russia.

Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Charité-Universitätsmedizin Berlin, Berlin, Germany.

出版信息

Clin Implant Dent Relat Res. 2025 Apr;27(2):e70043. doi: 10.1111/cid.70043.

Abstract

OBJECTIVES

To compare the efficacy of the connective tissue graft (SCTG) and the collagen matrix (VXCM) in terms of soft tissue gain at the buccal site around a single implant.

METHODS

The study was designed as a randomized, controlled clinical trial. This trial was registered in ClinicalTrial.gov with the identifier NCT05870774 and is accessible under the following link: https://clinicaltrials.gov/study/NCT05870774?term=NCT05870774&rank=1. This clinical trial was not registered prior to participant recruitment and randomization. Patients with a single tooth gap and horizontal soft tissue thickness deficiency were enrolled in the study. Sites were randomly allocated to the control (SCTG) or test group (VXCM: Geistlich Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland) to augment buccal soft tissue thickness. The primary outcome was soft tissue gain 3 months post-op. Secondary outcomes included soft tissue gain 6 months post-op, the pink aesthetic score (PES), and patient-reported outcome measures (PROMs).

RESULTS

Patients' recruitment started on 28 October 2021 and ended on 25 December 2022. Thirty-two patients were enrolled and subjected to intervention. Sixteen patients were included per group. Three months post-op, soft tissue gain at the buccal site was 1.77 ± 0.61 mm in the VXCM group and 1.26 ± 0.41 mm in the SCTG group (p = 0.0003). Six months post-op, soft tissue gain was 1.11 ± 0.44 mm in the VXCM group and 1.43 ± 0.81 mm in the SCTG group (p = 0.0459). PROMs, including pain perception, favored the VXCM group. SCTG demonstrated favored results in PES.

CONCLUSION

SCTG remains the gold standard for increasing soft tissue thickness in terms of the clinical result.

摘要

目的

比较结缔组织移植(SCTG)和胶原基质(VXCM)在单颗种植体颊侧部位软组织增量方面的疗效。

方法

本研究设计为一项随机对照临床试验。该试验已在ClinicalTrial.gov上注册,标识符为NCT05870774,可通过以下链接访问:https://clinicaltrials.gov/study/NCT05870774?term=NCT05870774&rank=1。本临床试验在招募参与者和进行随机分组之前未进行注册。纳入单颗牙间隙且水平软组织厚度不足的患者。将种植位点随机分配至对照组(SCTG)或试验组(VXCM:Geistlich Fibro-Gide,Geistlich Pharma AG,瑞士沃尔胡森),以增加颊侧软组织厚度。主要结局指标为术后3个月时的软组织增量。次要结局指标包括术后6个月时的软组织增量、粉色美学评分(PES)以及患者报告结局指标(PROMs)。

结果

患者招募于2021年10月28日开始,2022年12月25日结束。共纳入32例患者并接受干预,每组16例。术后3个月,VXCM组颊侧部位的软组织增量为1.77±0.61mm,SCTG组为1.26±0.41mm(p = 0.0003)。术后6个月,VXCM组软组织增量为1.11±0.44mm,SCTG组为1.43±0.81mm(p = 0.0459)。PROMs(包括疼痛感知)方面,VXCM组表现更佳。SCTG组在PES方面表现更佳。

结论

就临床结果而言,SCTG仍是增加软组织厚度的金标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4414/12010062/20945732e706/CID-27-0-g002.jpg

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