NCT05750745

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

A 12-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Detailed description

This study will be a single center, randomized, 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 12 weeks, to investigate the clinical efficacy of a SnF2 toothpaste for the relief of DH in a Chinese population. The SnF2 test dentifrice will be compared to commercialized negative and positive control toothpastes.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DRUG	Sensodyne Sensitivity & Gum	Sensodyne Sensitivity \& Gum toothpaste is containing 0.454% w/w SnF2.
DRUG	Crest Cavity Protection Fresh Lime	Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).
DRUG	Sensodyne Repair and Protect	Sensodyne Repair and Protect toothpaste is containing 5.0% w/w calcium sodium phosphosilicate (CSPS).

Timeline

• Start date: 2023-05-08
• Primary completion: 2023-09-19
• Completion: 2023-09-19
• First posted: 2023-03-02
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

1 site across 1 country: China