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

Abstract

ObjectiveTo 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). Methods30 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. ResultsUsing 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. ConclusionUsing 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 SignificanceTreatment with a toothpaste containing Steareth 30 surfactant generated fewer transient soft tissue lesions (lower desquamation) compared to a toothpaste containing SLS surfactant.