NCT04950465

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population

An 8 Week, Randomised, Examiner-blind, Controlled Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to support long-term dentinal hypersensitivity (DH) relief claims of 0.454 percent (%) stannous fluoride (SnF2) containing toothpastes in China.

Detailed description

This study will be a single centre, randomised, controlled, examiner-blind, 3 treatment arm, parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the 2 selected 'test teeth'), with a treatment period of 8 weeks, to investigate the clinical efficacy of a SnF2 dentifrice in the reduction of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialised negative and positive control dentifrices. Participants will be instructed to brush teeth with their assigned dentifrice according to the product use instructions provided. DH assessments will be conducted at Baseline, 4 and 8 weeks. Participants will also be requested to complete a short-form version of the Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) at the Baseline and Week 8 Visits.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	Sensodyne Sensitivity & Gum	Sensodyne Sensitivity \& Gum toothpaste containing 0.454% SnF2.
OTHER	Crest Cavity Protection Fresh Lime	Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.
OTHER	Sensodyne Repair and Protect	Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.

Timeline

• Start date: 2021-07-27
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2021-07-06
• Last updated: 2023-10-23
• Results posted: 2023-10-23

Locations

1 site across 1 country: China