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1%阿仑膦酸钠凝胶作为局部药物递送系统治疗慢性牙周炎的临床疗效:一项随机、对照临床试验。

Clinical efficacy of 1% alendronate gel as a local drug delivery system in the treatment of chronic periodontitis: a randomized, controlled clinical trial.

机构信息

Department of Periodontics, Government Dental College and Research Institute, Bangalore, India.

出版信息

J Periodontol. 2012 Jan;83(1):11-8. doi: 10.1902/jop.2011.110091. Epub 2011 May 4.

DOI:10.1902/jop.2011.110091
PMID:21542734
Abstract

BACKGROUND

Alendronate (ALN), an aminobisphosphonate, is known to inhibit osteoclastic bone resorption and was proposed to have osteostimulative properties in vivo and in vitro as shown by an increase in matrix formation. The present study aims to explore the efficacy of a 1% ALN gel compared to a placebo gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.

METHODS

A total of 66 intrabony defects were treated with a 1% ALN or placebo gel. The ALN gel was prepared by adding ALN to a polyacrylic acid-distilled water mixture. Clinical parameters (modified sulcus bleeding index, plaque index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline and 2 and 6 months, and radiographic parameters at baseline and 6 months. The defect fill at baseline and 6 months was calculated on standardized radiographs by using image-analysis software.

RESULTS

The mean PD reduction and CAL gain were greater in the ALN group than in the placebo group at 2 and 6 months. Furthermore, a significantly greater mean percentage of bone fill was found in the ALN group (40.4% ± 11.71%) than in the placebo group (2.5% ± 1.02%).

CONCLUSIONS

Results of the present study shows that the local delivery of 1% ALN into the periodontal pocket stimulated a significant increase in PD reduction, CAL gain, and improved bone fill compared to a placebo gel as an adjunct to SRP. These results can provide a new direction in the field of periodontal healing.

摘要

背景

阿仑膦酸钠(ALN)是一种氨基双膦酸盐,已知可抑制破骨细胞的骨吸收,并在体内和体外表现出骨刺激特性,表现为基质形成增加。本研究旨在探索 1% ALN 凝胶作为局部药物输送系统与龈下刮治和根面平整(SRP)联合治疗慢性牙周炎患者的骨内缺损的疗效。

方法

共有 66 个骨内缺损接受了 1% ALN 或安慰剂凝胶治疗。ALN 凝胶通过将 ALN 添加到聚丙烯酸-蒸馏水混合物中制备而成。在基线和 2 个月、6 个月时记录临床参数(改良龈沟出血指数、菌斑指数、探诊深度 [PD] 和临床附着水平 [CAL]),并在基线和 6 个月时记录放射学参数。使用图像分析软件在标准化 X 光片上计算基线和 6 个月时的缺损填充。

结果

在 2 个月和 6 个月时,ALN 组的 PD 减少和 CAL 增加均大于安慰剂组。此外,ALN 组的平均骨填充百分比(40.4%±11.71%)显著高于安慰剂组(2.5%±1.02%)。

结论

本研究结果表明,与安慰剂凝胶作为 SRP 的辅助治疗相比,将 1% ALN 局部输送到牙周袋中可刺激 PD 减少、CAL 增加和骨填充改善,这为牙周愈合领域提供了新的方向。

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