NCT06733285

Clinical Study to Investigate the Ability of a Stannous Fluoride Toothpaste to Protect From Dentine Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate and characterize the Dentine Hypersensitivity (DH) protection profiles of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste and a regular fluoride toothpaste, in response to evaporative air (Schiff sensitivity score) and tactile (tactile threshold in grams \[g\]) stimuli, with twice daily brushing over 2 weeks.

Detailed description

This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70 years, with self-reported and clinically confirmed DH. Participants who meet the required study criteria at screening and baseline will be randomized to one of two study toothpastes: 0.454% SnF2 toothpaste (Test) or a regular fluoride toothpaste (Negative Control). Sufficient participants will be screened to ensure approximately 80 participants are randomized to study toothpaste (approximately 40 participants per group) and approximately 70 participants complete the study (approximately 35 participants per group).

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	Sensodyne Rapid Relief	Toothpaste containing 0.454 % weight/weight (w/w) SnF2 (1100 parts per million \[ppm\] fluoride).
DRUG	Colgate Cavity Protection	A regular fluoride toothpaste containing 1000 ppm fluoride.

Timeline

• Start date: 2025-02-04
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2024-12-13
• Last updated: 2025-06-03

Locations

1 site across 1 country: United Kingdom