NCT06045026

A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers. Data generated will provide real world information on the DH experience and DH management with a daily use anti-sensitivity treatment.

Detailed description

This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Stannous fluoride	Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride

Timeline

• Start date: 2023-09-21
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2023-09-21
• Last updated: 2025-04-24
• Results posted: 2025-04-24

Locations

1 site across 1 country: United States