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一项关于洗必泰 xanthan 凝胶用于龈下应用的临床和微生物疗效的随机临床试验。

A randomized clinical trial on the clinical and microbiological efficacy of a xanthan gel with chlorhexidine for subgingival use.

机构信息

Section of Graduate Periodontology, Faculty of Dentistry, Complutense University, Plaza Ramón y Cajal S/N, 28040, Madrid, Spain.

出版信息

Clin Oral Investig. 2013 Jan;17(1):55-66. doi: 10.1007/s00784-012-0685-5. Epub 2012 Feb 16.

DOI:10.1007/s00784-012-0685-5
PMID:22350036
Abstract

BACKGROUND

The main indication of the adjunctive use of local antimicrobials lies around situations in which the outcome of non-surgical mechanical treatment results in a limited number of residual pockets. The purpose of this investigation was to evaluate the clinical and microbiological effects of the subgingival application of a xanthan-based 1.5% chlorhexidine (CHX) gel (Xan-CHX), adjunctive to scaling and root planing (SRP) in localized periodontitis.

METHODS

Periodontitis patients with four to ten residual (after conventional SRP) or relapsing (during supportive periodontal treatment) pockets were recruited and randomized to receive SRP plus the subgingival application of (Xan-CHX) or SRP plus a placebo gel. Supragingival plaque, bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level were evaluated with a computerized probe at baseline, and after 1, 3, and 6 months. Subgingival samples were also collected for the microbiological analysis. Statistical analysis used ANOVA and chi-square tests.

RESULTS

Overall, the clinical results were better in the test group, with significant changes in BOP (between baseline and 3 months) and with a significant increase in the proportion of shallow pockets (1-3 mm) at 6 months. These results did not result in significant intergroup differences. The microbiological impact was limited in both treatment groups.

CONCLUSION

The adjunctive use of Xan-CHX may improve, although to a limited extent, the clinical outcomes (BOP and PPD), in chronic periodontitis patients with "residual" or "relapsing" pockets, but no significant differences were detected between groups. No side effects, neither clinical nor microbiological, were detected after the use of the test product.

CLINICAL RELEVANCE

Adjunctive use of slow-released chlorhexidine might be considered in the management of periodontal disease and gingival inflammation to reduce the need for periodontal surgery.

摘要

背景

局部使用抗菌剂的主要适应证是在非手术机械治疗结果导致少数残留牙周袋的情况下。本研究旨在评估局部牙周炎患者在牙周基础治疗的基础上,辅助使用基于黄原胶的 1.5%洗必泰(CHX)凝胶(Xan-CHX)进行龈下局部应用的临床和微生物学效果。

方法

招募了 4 至 10 个(常规 SRP 后)或复发(在支持性牙周治疗期间)残留牙周袋的牙周炎患者,并随机分为 SRP 加龈下应用(Xan-CHX)或 SRP 加安慰剂凝胶组。在基线时以及 1、3 和 6 个月时,使用计算机探针评估龈上菌斑、探诊出血(BOP)、探诊袋深度(PPD)和临床附着水平。还收集龈下样本进行微生物分析。统计分析采用方差分析和卡方检验。

结果

总体而言,试验组的临床结果更好,BOP(与基线相比 3 个月)有显著变化,6 个月时浅袋(1-3mm)比例显著增加。这些结果在两组之间没有显著差异。两组治疗的微生物学影响均有限。

结论

Xan-CHX 的辅助使用可能会改善慢性牙周炎患者“残留”或“复发”牙周袋的临床效果(BOP 和 PPD),尽管程度有限,但在两组之间未检测到显著差异。使用试验产品后未发现临床或微生物学方面的不良反应。

临床意义

辅助使用缓慢释放的洗必泰可能有助于减少牙周手术的需要,从而控制牙周病和牙龈炎症。

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