一项随机临床试验比较了含有 Steareth 30 和 SLS 的牙膏对口腔上皮完整性（脱屑）的影响。

A randomised clinical study comparing the effect of Steareth 30 and SLS containing toothpastes on oral epithelial integrity (desquamation).

机构信息

Unilever Oral Care, Quarry Road East, Bebington, Wirral, CH63 3JW, UK.

Birmingham Dental Hospital and School of Dentistry, 5 Mill Pool Way, Birmingham, B5 7EG, UK.

出版信息

J Dent. 2019 Jan;80 Suppl 1:S33-S39. doi: 10.1016/j.jdent.2018.11.005.

DOI:10.1016/j.jdent.2018.11.005

PMID:30696554

Abstract

OBJECTIVE

To compare the clinical effect of toothpastes containing Steareth 30 and SLS (sodium lauryl sulphate) surfactants on oral epithelial integrity (desquamation) using a new Oral Mucosal Sloughing Index (OMSI).

METHODS

30 volunteers participated in a single centre, double-blind, randomised, crossover clinical study. After a lead-in, subjects were allocated to the first test toothpaste, which was applied to the maxilla via a cap splint, followed by whole mouth brushing with the respective toothpaste and rinsing with the toothpaste slurry. Soft desquamation (lesion status) was assessed using a novel Oral Mucosal Sloughing Index (OMSI). Soft tissue status was measured at baseline (prior to test product use), 30 min following test product application and 4 days later following "at home" use of test toothpaste. After a wash out period, soft tissue assessment and product use were repeated for the remaining toothpaste.

RESULTS

Using the OMSI, 30 min post-application, significantly fewer lesion counts (all sites) were observed for the Steareth 30 toothpaste compared to SLS toothpaste (p < 0.0001). Additionally, 30 min after toothpaste use, the average lesion severity score was significantly lower for the Steareth 30 toothpaste compared to SLS toothpaste (p < 0.0001). There were no significant differences in lesion status at baseline or following 4 days of "at home" use of the toothpastes. No product related adverse events were reported.

CONCLUSION

Using an Oral Mucosal Sloughing Index for assessment, application of a toothpaste containing Steareth 30 generated significantly less transient soft tissue desquamation (fewer lesion counts and lower severity) than a toothpaste containing SLS.

CLINICAL SIGNIFICANCE

Treatment with a toothpaste containing Steareth 30 surfactant generated fewer transient soft tissue lesions (lower desquamation) compared to a toothpaste containing SLS surfactant.

摘要

目的

使用新的口腔黏膜脱落指数（OMSI）比较含有 Steareth 30 和 SLS（月桂基硫酸钠）表面活性剂的牙膏对口腔上皮完整性（脱皮）的临床效果。

方法

30 名志愿者参加了一项单中心、双盲、随机、交叉临床试验。在导入期后，受试者被分配到第一个测试牙膏，通过帽夹板应用于上颌，然后用各自的牙膏进行全口刷牙并用牙膏浆漱口。使用新型口腔黏膜脱落指数（OMSI）评估软脱落（病变状态）。在使用测试产品之前（基线）、使用测试产品 30 分钟后以及使用测试牙膏“在家”后 4 天测量软组织状态。在洗脱期后，重复使用剩余牙膏进行软组织评估和产品使用。

结果

使用 OMSI，应用后 30 分钟，Steareth 30 牙膏的病变计数（所有部位）明显少于 SLS 牙膏（p<0.0001）。此外，使用牙膏后 30 分钟，Steareth 30 牙膏的平均病变严重程度评分明显低于 SLS 牙膏（p<0.0001）。基线或使用牙膏“在家”4 天后，病变状态无显着差异。未报告与产品相关的不良事件。