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评价含蒲丁提取物牙膏抑制牙菌斑和减轻慢性牙龈炎效果的随机、双盲、平行对照临床试验。

Evaluation of the effect of a toothpaste containing Pudilan extract on inhibiting plaques and reducing chronic gingivitis: A randomized, double-blinded, parallel controlled clinical trial.

机构信息

State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China.

State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu 610041, Sichuan, China; Department of Pediatric, Jinan Stomatology Hospital, Jinan, China.

出版信息

J Ethnopharmacol. 2019 Aug 10;240:111870. doi: 10.1016/j.jep.2019.111870. Epub 2019 Apr 11.

DOI:10.1016/j.jep.2019.111870
PMID:30980892
Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Pudilan is a famous traditional Chinese medicine compound which contains several Chinese herbal ingredients, and has been wildly used to treat a variety of inflammatory diseases in China. Recently, it was reported that Pudilan extract had been used in the oral field, especially in the treatment of minor oral ulcers for its anti-inflammatory, pain relieving, antibacterial, clearing heat, and detoxifying effects.

AIM OF THE STUDY

To evaluate the effectiveness and safety of Pudilan extract-containing toothpaste in controlling plaques and reducing chronic gingivitis.

MATERIALS AND METHODS

A total of 120 patients with chronic gingivitis were randomized into an experiment group and a control group (n = 60 patients per group) based on a double-blinded method. Patients in the experiment group used a Pudilan extract-containing toothpaste, whereas patients in the control group used a Pudilan toothpaste simulator, which were identical as the toothpaste used by the experiment group, except for not containing the Pudilan extract. The Plaque Index (PI), Gingival Index (GI), Bleeding Index (BI), and Bleeding On Probing proportion (BOP%) were recorded at baseline, 4 weeks, 8 weeks and 12 weeks after using the toothpaste.

RESULTS

After using the toothpaste for 8 and 12 weeks, PI, BI, GI, and BOP% of the experiment group were significantly lower when compared to the control group (both p < 0.001). Moreover, after using the toothpaste for 4, 8, and 12 weeks, the decline of the PI and GI in the experiment group were significantly higher than the control group (p < 0.001, except 4weeks PI p = 0.011). After 12 weeks, the PI of the experiment group decreased 35.73% (p < 0.001) whereas the GI decreased 29.04% (p < 0.001). BI and BOP decline rates were statistically significant when compared to those of the control group at 8 and 12 weeks (both p < 0.001). Moreover, at 12 weeks, the BI of the experiment group decreased 34.33% (p < 0.001) and BOP% decreased 54.71% (p < 0.001).

CONCLUSION

Toothpaste with Pudilan extract demonstrated good effect on relieving symptoms of chronic gingivitis by inhibiting plaque formation, reducing gingival inflammation and the degree of bleeding, and the bleeding rate. Toothpaste containing Pudilan extract has prospective application potentials in the prevention and treatment of chronic gingivitis.

摘要

民族药理学相关性

蒲地蓝是一种著名的中药复方,含有多种中草药成分,在中国被广泛用于治疗各种炎症性疾病。最近有报道称,蒲地蓝提取物已在口腔领域中使用,特别是在治疗轻度口腔溃疡方面,具有抗炎、止痛、抗菌、清热、解毒的作用。

目的

评价含蒲地蓝提取物的牙膏控制菌斑和减轻慢性牙龈炎的有效性和安全性。

材料和方法

将 120 例慢性牙龈炎患者按双盲法分为实验组和对照组(每组 60 例)。实验组使用含蒲地蓝提取物的牙膏,对照组使用蒲地蓝牙膏模拟剂,除不含蒲地蓝提取物外,与实验组使用的牙膏完全相同。在使用牙膏前、使用后 4 周、8 周和 12 周记录菌斑指数(PI)、牙龈指数(GI)、出血指数(BI)和探诊出血比例(BOP%)。

结果

使用牙膏 8 周和 12 周后,实验组的 PI、BI、GI 和 BOP%明显低于对照组(均 p<0.001)。此外,使用牙膏 4 周、8 周和 12 周后,实验组 PI 和 GI 的下降幅度明显高于对照组(p<0.001,除 4 周 PI 外 p=0.011)。使用 12 周后,实验组的 PI 下降了 35.73%(p<0.001),GI 下降了 29.04%(p<0.001)。与对照组相比,BI 和 BOP 的下降率在 8 周和 12 周时均有统计学意义(均 p<0.001)。此外,实验组在 12 周时 BI 下降了 34.33%(p<0.001),BOP%下降了 54.71%(p<0.001)。

结论

含蒲地蓝提取物的牙膏通过抑制菌斑形成、减轻牙龈炎症和出血程度及出血率,对缓解慢性牙龈炎症状有较好的效果。含蒲地蓝提取物的牙膏在预防和治疗慢性牙龈炎方面具有潜在的应用前景。

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