NCT03598881

A Study to Assess the Impact of a Non-SLS Toothpaste Upon Oral Mucosal Desquamation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is to compare the effect on oral mucosal desquamation of a non-SLS toothpaste and an SLS-containing toothpaste..

Detailed description

Subjects will use a wash out toothpaste for at least 10 days prior to each leg of the crossover design. Clinical assessment of oral mucosa status will be performed by a trained examiner before supervised product application, 30 minutes after product application and again after 4 days of twice daily brushing with product. Supervised product application consists of cap splint application of allocated toothpaste to maxillary arch followed by brushing whole mouth with toothpaste and swishing with resultant slurry around the mouth. For visual sloughing evaluation, the oral mucosa will be divided into 12 assessment areas and each area evaluated for severity of sloughing on a 0 to 5 scale. The following outcomes will be generated from the sloughing data: 1. Whole mouth data per subject: each non-zero severity score will be treated as one lesion count, giving a maximum score of 12; 2. Subject level mucosal severity sloughing score: severity score averaged over the 12 areas assessed.

Conditions

• Sloughing Skin
• Mucosal Inflammation

Interventions

Type	Name	Description
OTHER	Treatment

Timeline

• Start date: 2016-09-19
• Primary completion: 2016-11-21
• Completion: 2016-11-21
• First posted: 2018-07-26
• Last updated: 2018-07-26

Locations

1 site across 1 country: United Kingdom