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FGF-2 促进牙周组织再生:多中心随机临床试验结果。

FGF-2 stimulates periodontal regeneration: results of a multi-center randomized clinical trial.

机构信息

Department of Periodontology, Division of Oral Biology and Disease Control, Osaka University Dental Hospital, Japan.

出版信息

J Dent Res. 2011 Jan;90(1):35-40. doi: 10.1177/0022034510384616. Epub 2010 Nov 8.

DOI:10.1177/0022034510384616
PMID:21059869
Abstract

The efficacy of the local application of recombinant human fibroblast growth factor-2 (FGF-2) in periodontal regeneration has been investigated. In this study, a randomized, double-blind, placebo-controlled clinical trial was conducted in 253 adult patients with periodontitis. Modified Widman periodontal surgery was performed, during which 200 µL of the investigational formulation containing 0% (vehicle alone), 0.2%, 0.3%, or 0.4% FGF-2 was administered to 2- or 3-walled vertical bone defects. Each dose of FGF-2 showed significant superiority over vehicle alone (p < 0.01) for the percentage of bone fill at 36 wks after administration, and the percentage peaked in the 0.3% FGF-2 group. No significant differences among groups were observed in clinical attachment regained, scoring approximately 2 mm. No clinical safety problems, including an abnormal increase in alveolar bone or ankylosis, were identified. These results strongly suggest that topical application of FGF-2 can be efficacious in the regeneration of human periodontal tissue that has been destroyed by periodontitis.

摘要

已经研究了局部应用重组人成纤维细胞生长因子-2(FGF-2)在牙周再生中的功效。在这项研究中,对 253 名患有牙周炎的成年患者进行了一项随机、双盲、安慰剂对照的临床试验。进行了改良的 Widman 牙周手术,在此期间,将含有 0%(仅载体)、0.2%、0.3%或 0.4%FGF-2 的研究制剂 200µL 施用于 2 壁或 3 壁垂直骨缺损。与单独使用载体相比,每种 FGF-2 剂量在给药后 36 周时的骨填充百分比均显示出显著优势(p<0.01),并且在 0.3%FGF-2 组中达到峰值。各组之间在临床附着体恢复方面没有观察到显著差异,约为 2mm。未发现包括牙槽骨异常增加或骨粘连在内的临床安全问题。这些结果强烈表明,局部应用 FGF-2 可有效促进牙周炎破坏的人牙周组织的再生。

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