NCT04601103

3M Oral Rinse Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

3M Oral Rinse Evaluation of Incidence and Patient Acceptance of Sloughing When Used With Sodium Lauryl Sulfate (SLS) Toothpastes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations.

Detailed description

The primary objective of this study is to evaluate the incidence of oral tissue sloughing through self-report by study subjects and by professional dental examinations. Adverse events will be tracked through study dental examinations and subject diaries with twice daily use of the 3M Oral Rinse used in combination with toothpaste containing one of three levels (no, medium, high) of Sodium Lauryl Sulfate (SLS). Determine the subjects' acceptance of sloughing and/or other side effects

Conditions

• Oral Mucosal Disorder

Interventions

Type	Name	Description
DRUG	No SLS toothpaste	Toothpaste no Sodium Lauryl Sulfate
DRUG	Medium SLS toothpaste	Less than or equal to X ppm Sodium Lauryl Sulfate
DRUG	High SLS toothpaste	More than or equal to X ppm Sodium Lauryl Sulfate
DEVICE	Anti-plaque	Rinse prevents bacterial adherence to teeth

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2020-10-23
• Last updated: 2024-10-01
• Results posted: 2021-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study