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辅助递送次氯酸钠凝胶治疗种植体周围黏膜炎的抗感染治疗:一项为期 6 个月的随机三盲对照临床试验。

Anti-infective therapy of peri-implant mucositis with adjunctive delivery of a sodium hypochlorite gel: a 6-month randomized triple-blind controlled clinical trial.

机构信息

Department of Periodontology, University of Naples Federico II, Via S Pansini 5, Piata, 80131, Naples, Italy.

Department of Health Sciences, School of Dental Medicine, University of Catanzaro, Viale Europa Località Germaneto, 88100, Catanzaro, Italy.

出版信息

Clin Oral Investig. 2020 Jun;24(6):1971-1979. doi: 10.1007/s00784-019-03060-2. Epub 2019 Aug 21.

Abstract

OBJECTIVE

To evaluate the effects of adjunctive delivery of a sodium hypochlorite gel in the treatment of peri-implant mucositis (PM).

MATERIALS AND METHODS

Forty-six subjects with 68 implants diagnosed with PM were randomly assigned to two treatment groups. Prior to mechanical debridement, a sodium hypochlorite gel was delivered to the implants of the test group while implants of the control group received a placebo gel. Application of both test and placebo gels was repeated 5 times at baseline. The primary outcome variable was the change in pocket probing depth (PPD) between baseline and 6 months.

RESULTS

After 6 months, the mean PPD decreased statistically significantly from 3.93 ± 1.09 mm to 3.04 ± 0.46 mm in the test (p = 0.0001) and from 3.68 ± 0.85 mm to 3.07 ± 0.58 mm in the control (p = 0.0001) group, respectively. No statistically significant difference (p = 0.53) was observed with respect to PPD changes from baseline to 6 months between test (0.88 ± 1.04 mm) and control group (0.61 ± 0.75 mm), respectively. The number of implants with bleeding on probing (BoP) decreased statistically significantly from 33 to 18 in the test group (p = 0.0001) and from 34 to 23 in the control group (p = 0.0001) after 6 months.

CONCLUSIONS

In conclusion and within the limits of the present study, changes in PPD from baseline to 6 months were not statistically significantly different between groups. Complete resolution of mucosal inflammation was not achieved with either of the therapies.

CLINICAL RELEVANCE

The present outcomes have showed that a complete resolution of peri-implant mucositis is not possible to obtain by means mechanical debridement with or without a sodium hypochlorite gel application.

摘要

目的

评估在治疗种植体周围黏膜炎(PM)时辅助使用次氯酸钠凝胶的效果。

材料与方法

将 46 名患有 PM 的 68 个种植体的受试者随机分配到两组。在机械清创前,将次氯酸钠凝胶施用于实验组的种植体,而对照组的种植体则使用安慰剂凝胶。在基线时重复使用测试和安慰剂凝胶各 5 次。主要观察变量是从基线到 6 个月时的探诊深度(PPD)变化。

结果

6 个月后,实验组的平均 PPD 从 3.93±1.09mm 显著下降至 3.04±0.46mm(p=0.0001),对照组从 3.68±0.85mm 下降至 3.07±0.58mm(p=0.0001)。两组从基线到 6 个月的 PPD 变化无统计学差异(p=0.53),实验组为 0.88±1.04mm,对照组为 0.61±0.75mm。实验组探诊出血(BoP)的种植体数量从 33 个显著减少至 18 个(p=0.0001),对照组从 34 个减少至 23 个(p=0.0001)。

结论

在本研究的范围内,从基线到 6 个月的 PPD 变化在两组之间无统计学差异。两种治疗方法均未能完全消除黏膜炎症。

临床相关性

本研究结果表明,通过机械清创辅以或不辅以次氯酸钠凝胶应用,无法完全治愈种植体周围黏膜炎。

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