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1%阿仑膦酸钠凝胶辅助机械疗法治疗侵袭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 in adjunct to mechanotherapy in the treatment of aggressive periodontitis: a randomized controlled clinical trial.

机构信息

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

出版信息

J Periodontol. 2012 Jan;83(1):19-26. doi: 10.1902/jop.2011.110206. Epub 2011 May 24.

DOI:10.1902/jop.2011.110206
PMID:21609254
Abstract

BACKGROUND

Bisphosphonates represent a class of pharmacologic agents that have a potentially important role in the treatment of periodontitis and bone disorders. The present study aims to explore the clinical efficacy of 1% alendronate (ALN) gel as a local drug delivery system in adjunct to scaling and root planing for the treatment of patients with aggressive periodontitis (AgP) compared to placebo gel.

METHODS

Fifty-two intrabony defects from 17 patients with AgP were treated either with 1% ALN gel or placebo gel. 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, 2 months, and 6 months, and radiographic parameters were recorded at baseline and 6 months. Defect fill at baseline and at 6 months was calculated on standardized radiographs by using image analysis software.

RESULTS

Mean PD reduction was greater in the ALN group (3.88 ± 1.39 mm) compared to placebo (1.65 ± 1.35 mm) at 6 months. Similarly, mean CAL gain was greater in the ALN group (3.27 ± 1.11 mm) than the placebo group (1.42 ± 1.70 mm) at 6 months. Furthermore, significantly greater mean percentage of bone fill was found in the ALN group (46.1% ± 9.48%) compared to the placebo group (2% ± 1.02%).

CONCLUSIONS

The results of the present study show local delivery of 1% ALN stimulates a significant increase in PD reduction, CAL gain, and improved bone fill compared to placebo gel as an adjunct to scaling and root planing in patients with AgP. However, long-term, multicentered, randomized, controlled clinical trials are required to know the clinical, histologic, and radiographic effect on bone regeneration in patients with AgP.

摘要

背景

双膦酸盐是一类具有重要治疗牙周炎和骨骼疾病潜力的药物。本研究旨在探讨 1%阿仑膦酸钠(ALN)凝胶作为局部药物输送系统,与牙周刮治和根面平整联合应用于侵袭性牙周炎(AgP)患者的临床疗效,与安慰剂凝胶相比。

方法

17 例侵袭性牙周炎患者的 52 个骨内缺损分别用 1%阿仑膦酸钠凝胶或安慰剂凝胶治疗。ALN 凝胶通过将 ALN 加入聚丙烯酸-蒸馏水混合物中制备而成。在基线、2 个月和 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]),在基线和 6 个月时记录放射学参数。在基线和 6 个月时,使用图像分析软件对标准化 X 线片上的缺损填充进行计算。

结果

6 个月时,ALN 组 PD 平均减少(3.88±1.39)mm,明显大于安慰剂组(1.65±1.35)mm。同样,ALN 组 CAL 平均增加(3.27±1.11)mm,明显大于安慰剂组(1.42±1.70)mm。此外,ALN 组的平均骨填充百分比(46.1%±9.48%)明显大于安慰剂组(2%±1.02%)。

结论

本研究结果表明,与牙周刮治和根面平整联合应用时,局部给予 1%ALN 可显著促进 PD 减少、CAL 增加和骨填充改善,优于安慰剂凝胶。然而,需要进行长期、多中心、随机、对照临床试验,以了解 AgP 患者的临床、组织学和放射学对骨再生的影响。

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