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富含血小板纤维蛋白与脱细胞真皮基质用于牙种植同期垂直软组织增量:一项为期3个月的随机对照临床试验

Platelet-rich fibrin versus acellular dermal matrix for vertical soft tissue augmentation simultaneously with dental implantation: a 3-month randomized pilot clinical trial.

作者信息

Shiezadeh Farid, Moeintaghavi Amir, Moslehitabar Zahra, Khojaste Moein

机构信息

Dental Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Periodontics, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.

出版信息

BMC Oral Health. 2025 Jul 2;25(1):1060. doi: 10.1186/s12903-025-06394-4.

Abstract

BACKGROUND

Vertical soft tissue thickness is critical for peri-implant health and aesthetics. Platelet-rich fibrin (PRF) and acellular dermal matrix (ADM) are increasingly used for soft tissue augmentation during dental implantation, but direct comparisons of their efficacy are limited. This study aimed to compare the efficacy of PRF and ADM for vertical soft tissue augmentation, simultaneously with dental implantation.

METHODS

This pilot randomized controlled clinical trial included 20 patients with thin soft tissue phenotypes (≤ 2 mm) in the posterior mandible. Patients were randomly assigned to the PRF (n = 10) or ADM (n = 10) groups. The primary outcome was gingival thickness measured at baseline and three months postoperatively via a #15 endodontic file and a digital caliper. The Shapiro-Wilk test was used to assess data normality. Data were analyzed via independent and paired t-tests for normally distributed data and Mann-Whitney and Wilcoxon tests for non-normally distributed data. Chi-square tests and Fisher's exact tests used to compare sex distribution between groups. Between-group comparisons at baseline and three months were performed, with significance set at P < 0.05.

RESULTS

The baseline gingival thickness did not differ significantly between the groups (P = 0.19). At three months, gingival thickness significantly increased in both the PRF (from 1.66 ± 0.23 mm to 3.30 ± 0.75 mm) and ADM (from 1.52 ± 0.22 mm to 2.58 ± 0.47 mm) groups (P < 0.001 for both). Although the gingival thickness at three months was significantly greater in the PRF group (p = 0.02), the mean soft tissue gain was not significantly different between the groups (P = 0.081).

CONCLUSIONS

Both PRF and ADM significantly increased gingival thickness three months post-surgery, with PRF resulting in greater overall thickness. These preliminary findings support using PRF and ADM as effective options for vertical soft tissue augmentation during dental implantation. However, given the pilot nature of this study, further research with larger sample sizes and longer follow-up periods is needed to validate these results.

TRIAL REGISTRATION

This project was registered in the Iranian Registry of Clinical Trials under the ID (IRCT20200914048713N1) and registration date 30/11/2021.

摘要

背景

垂直软组织厚度对种植体周围的健康和美观至关重要。富血小板纤维蛋白(PRF)和脱细胞真皮基质(ADM)在牙种植期间越来越多地用于软组织增量,但对它们疗效的直接比较有限。本研究旨在比较PRF和ADM在牙种植同时进行垂直软组织增量的疗效。

方法

这项前瞻性随机对照临床试验纳入了20例下颌后部软组织菲薄(≤2mm)的患者。患者被随机分配到PRF组(n = 10)或ADM组(n = 10)。主要结局是在基线和术后3个月通过15号根管锉和数字卡尺测量的牙龈厚度。采用Shapiro-Wilk检验评估数据正态性。对于正态分布的数据,通过独立样本t检验和配对t检验进行分析;对于非正态分布的数据,采用Mann-Whitney检验和Wilcoxon检验进行分析。采用卡方检验和Fisher精确检验比较两组之间的性别分布。在基线和3个月时进行组间比较,显著性设定为P < 0.05。

结果

两组之间的基线牙龈厚度无显著差异(P = 0.19)。在3个月时,PRF组(从1.66±0.23mm增加到3.30±0.75mm)和ADM组(从1.52±0.22mm增加到2.58±0.47mm)的牙龈厚度均显著增加(两组均P < 0.001)。虽然3个月时PRF组的牙龈厚度显著更大(P = 0.02),但两组之间的平均软组织增加量无显著差异(P = 0.081)。

结论

PRF和ADM在术后3个月均显著增加了牙龈厚度,PRF使总体厚度增加更多。这些初步研究结果支持将PRF和ADM作为牙种植期间垂直软组织增量的有效选择。然而,鉴于本研究的探索性质,需要进行更大样本量和更长随访期的进一步研究来验证这些结果。

试验注册

本项目在伊朗临床试验注册中心注册,注册号为(IRCT20200914048713N1),注册日期为2021年11月30日。

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