一种含有丹皮酚、硝酸钾和氯化锶的牙膏对牙本质过敏的疗效：一项针对中国成年人的双盲随机对照试验。

Efficacy of a toothpaste containing paeonol, potassium nitrate, and strontium chloride on dentine hypersensitivity: A double-blind randomized controlled trial in Chinese adults.

作者信息

Li Jia, Han Qi, Zhang Li, Zhang Jing, Zhong Yisi

机构信息

State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & State Institute of Medical Device Clinical Trial, 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 General Dentistry Ⅱ, West China Hospital of Stomatology, Sichuan University, 14#, 3rd Section, Renmin South Road, Chengdu, 610041, Sichuan, China.

出版信息

Heliyon. 2023 Mar 15;9(4):e14634. doi: 10.1016/j.heliyon.2023.e14634. eCollection 2023 Apr.

DOI:10.1016/j.heliyon.2023.e14634

PMID:37025919

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10070521/

Abstract

OBJECTIVE

The purpose of this randomized controlled trial was to compare the efficacy of a toothpaste containing paeonol, potassium nitrate, and strontium chloride with control toothpaste on dentine hypersensitivity (DH).

METHODS

DH patients who had at least two sensitive teeth and did not use desensitization toothpaste in the past 3 months were randomly allocated to either test or control group. The toothpaste containing paeonol, potassium nitrate, and strontium chloride was used in the test group, while the placebo toothpaste used in control group. The outcome measures included Yeaple probe score and Schiff Index score at 4 and 8 weeks. The patients, personnel and assessors were blinded to the allocation. The differences in Yeaple probe score and Schiff Index score between groups were analyzed with ANOVA.

RESULTS

91 eligible subjects were randomized. 88 of them completed 8-week follow-up and were analyzed (45 in the test group and 43 in the control group). In both groups, the Yeaple probe score showed an upward trend, while the Schiff sensitivity score showed a downward trend. At week 8, the Yeaple probe score had increased by 30.22 g in the test group, and the Schiff Index score had decreased by 0.89. Compared with the control group, the Yeaple probe score in the test group increased by 286.85% from baseline, and the Schiff Index score decreased by 42.96%, showing a statistically significant difference. Five cases of adverse events were observed.

CONCLUSION

The toothpaste containing paeonol, potassium nitrate, and strontium chloride was effective against DH.

CLINICAL SIGNIFICANCE

This combination of paeonol, potassium nitrate and strontium chloride could be a novel functional ingredient choice for anti-hypersensitivity products in future.

REGISTRATION

The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000041417).

摘要

目的

本随机对照试验旨在比较一款含有丹皮酚、硝酸钾和氯化锶的牙膏与对照牙膏对牙本质过敏症（DH）的疗效。

方法

选取过去3个月内至少有两颗敏感牙齿且未使用过脱敏牙膏的DH患者，随机分为试验组和对照组。试验组使用含有丹皮酚、硝酸钾和氯化锶的牙膏，对照组使用安慰剂牙膏。观察指标包括4周和8周时的Yeaple探针评分和Schiff指数评分。患者、研究人员和评估人员均对分组情况不知情。采用方差分析比较两组间Yeaple探针评分和Schiff指数评分的差异。

结果

91名符合条件的受试者被随机分组。其中88名完成了8周的随访并纳入分析（试验组45名，对照组43名）。两组的Yeaple探针评分均呈上升趋势，而Schiff敏感评分呈下降趋势。在第8周时，试验组的Yeaple探针评分增加了30.22克，Schiff指数评分下降了0.89。与对照组相比，试验组的Yeaple探针评分较基线增加了286.85%，Schiff指数评分下降了42.96%，差异具有统计学意义。观察到5例不良事件。