Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice

HALEON

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.

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; a…

Eligibility

Age range: 12–65 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Provision of signed and dated informed consent document (and assent document, if appropriate) * Participant is biologically male or female. * Participant is 12 to 65 years of age, inclusive, at the time of signing the consent/assent form. * Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or well-being, or the outcomes of the study, if they were to par…

Interventions

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

Locations (3)

All Sum Research Limited
Melbourne, Florida
Salus Research, Inc.
Fort Wayne, Indiana
Silverstone Research
Las Vegas, Nevada