NCT07215767

Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use.

Detailed description

This will be a multi-center, randomized, controlled, double-blind, 4-treatment arm, stratified, parallel design, Phase III clinical study in healthy participants, aged 12-65 years inclusive, with self-reported and clinically confirmed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be stratified and randomized to one of four study dentifrices. Approximately 630 qualifying participants will be randomized to study treatment (approximately 180 participants each to the SnF2 and KNO3 dentifrice, the SnF2 dentifrice and the KNO3 dentifrice; approximately 90 participants to the Vehicle dentifrice). Dentin hypersensitivity will be clinically assessed at Screening and Baseline, and after 3 days, 1 week, 2 weeks, 4 weeks and 8 weeks treatment (7 study visits).

Conditions

• Dentin Hypersensitivity

Interventions

Type	Name	Description
DRUG	Stannous fluoride and Potassium nitrate Dentifrice	Fluoride dentifrice
DRUG	Stannous fluoride Dentifrice	Fluoride dentifrice
DRUG	Potassium nitrate Dentifrice	Non-fluoride dentifrice
DRUG	Vehicle Dentifrice	Placebo dentifrice

Timeline

• Start date: 2025-09-16
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-10-10
• Last updated: 2026-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study