NCT05243745

Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth

An 8-week, Randomised, Controlled, Examiner-Blind, Proof of Principle Study Investigating the Ability of a 3% Methyl Vinyl Ether/Maleic Anhydride Co-Polymer (PVM/MA) + 5% Potassium Nitrate (KNO3) Combination Toothpaste to Protect From Dentine Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This proof of principle (PoP) study will evaluate the ability of an experimental combination toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.

Detailed description

This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth) clinical study in healthy participants with sensitive teeth.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
OTHER	3% PVM/MA + 5% KNO3 Combination	Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.
OTHER	3% PVM/MA only	Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.
OTHER	5% KNO3 Only	Toothpastes containing 5% KNO3 only will be used as comparator 2 product.
OTHER	Regular Fluoride	Toothpaste containing regular fluoride will be used as negative control.

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2022-02-17
• Last updated: 2024-09-20
• Results posted: 2024-09-20

Locations

1 site across 1 country: United Kingdom