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0.5%克拉霉素凝胶局部给药辅助非手术牙周治疗对慢性牙周炎伴吸烟患者的疗效:一项随机对照临床试验。

Efficacy of local drug delivery of 0.5% clarithromycin gel as an adjunct to non-surgical periodontal therapy in the treatment of current smokers with chronic periodontitis: a randomized controlled clinical trial.

机构信息

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

出版信息

J Periodontol. 2012 Sep;83(9):1155-63. doi: 10.1902/jop.2012.110600. Epub 2012 Jan 16.

DOI:10.1902/jop.2012.110600
PMID:22248223
Abstract

BACKGROUND

The relationship between cigarette smoking and periodontal disease has been examined extensively. Local delivery of antimicrobials into periodontal pockets improves periodontal health. The present study is designed to investigate the adjunctive effects of subgingivally delivered 0.5% clarithromycin (CLM) as an adjunct to scaling and root planing for treating chronic periodontitis in smokers.

METHODS

Sixty-one patients were randomized and categorized into two treatment groups: group 1, in which 31 individuals received scaling and root planing plus 0.5% CLM, and group 2, in which 30 individuals received scaling and root planing plus placebo gel. Clinical parameters were recorded at baseline and at 1, 3, and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), gingival index (GI), probing depth (PD), and clinical attachment level (CAL). The mean concentration of 0.5% CLM in gingival crevicular fluid (GCF) was estimated by reverse-phase high-performance liquid chromatography.

RESULTS

Both therapies resulted in significant improvements. At the end of 6 months, the mean GI, PI, mSBI, PD, and CAL for the CLM group were 1.06 ± 0.28, 2.82 ± 0.64, 1.36 ± 0.24, 4.64 ± 0.63, and 4.90 ± 0.46, respectively, versus 1.38 ± 0.41, 3.22 ± 0.57, 1.44 ± 0.27, 6.07 ± 0.88, and 5.69 ± 0.46, respectively, for the placebo group. Using an individual-based analysis, individuals in group 1 showed enhanced clinical outcome (P <0.05) over a period of 6 months compared with those in group 2. CLM was detected in GCF until a period of 7 weeks after the local drug delivery.

CONCLUSION

Although both treatment strategies seemed to benefit the individuals, the adjunctive use of 0.5% CLM as a controlled drug delivery system enhanced the clinical outcome.

摘要

背景

吸烟与牙周病之间的关系已被广泛研究。局部递送至牙周袋中的抗菌药物可改善牙周健康。本研究旨在探讨龈下给予 0.5%克拉霉素(CLM)作为牙周刮治和根面平整的辅助手段,治疗吸烟人群慢性牙周炎的辅助效果。

方法

将 61 名患者随机分为两组:组 1 中,31 名患者接受牙周刮治和根面平整加 0.5%CLM 治疗,组 2 中,30 名患者接受牙周刮治和根面平整加安慰剂凝胶治疗。在基线和 1、3 和 6 个月时记录临床参数,包括菌斑指数(PI)、改良龈沟出血指数(mSBI)、牙龈指数(GI)、探诊深度(PD)和临床附着水平(CAL)。通过反相高效液相色谱法估计龈沟液(GCF)中 0.5%CLM 的平均浓度。

结果

两种治疗方法均取得显著改善。6 个月结束时,CLM 组的平均 GI、PI、mSBI、PD 和 CAL 分别为 1.06 ± 0.28、2.82 ± 0.64、1.36 ± 0.24、4.64 ± 0.63 和 4.90 ± 0.46,而安慰剂组分别为 1.38 ± 0.41、3.22 ± 0.57、1.44 ± 0.27、6.07 ± 0.88 和 5.69 ± 0.46。采用个体基础分析,与组 2 相比,组 1 中的个体在 6 个月的时间内表现出更好的临床疗效(P<0.05)。CLM 在局部药物递送后 7 周内仍可在 GCF 中检测到。

结论

尽管两种治疗策略似乎都使个体受益,但将 0.5%CLM 作为控释药物递送系统的辅助使用增强了临床疗效。

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