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RECRUITINGNA

A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

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

NCT07352956•HALEON

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the clinical efficacy of a 0.454 percent (%) weight/weight (w/w) stannous fluoride (SnF2) toothpaste in reducing dentin hypersensitivity (DH) to an evaporative (air) stimulus and tactile stimulus after 28 and 56 days twice daily brushing.

Detailed Description

This will be a single center, randomized, controlled, examiner-blind, 2-arm, stratified, parallel design clinical study in healthy male and female participants, aged 18-70, with self-reported and clinically confirmed DH in a Chinese population in a study design as per the Chinese Ministry of Health (MOH) Guidance. Sufficient participants will be screened so that approximately 100 participants (50 per group) will be stratified according to the maximum baseline Schiff sensitivity score of their two 'Test Teeth' and randomized to ensure approximately 90 evaluable participants (45 per group) complete the study.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Provision of signed and dated informed consent document confirming the participant has been informed of all pertinent aspects of the study and has given their written consent for study participation before any study procedures are performed.
•Participant is biologically male or female.
•Participant is 18 to 70 years of age at the time of signing the consent form.
•Participant is willing and able to comply with the study visit schedule, toothpaste usage instructions, lifestyle restrictions, and other study procedures.
•Participant is in good general, oral, and mental health, which 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 wellbeing, or the outcomes of the study if they were to participate in the study, or affect their ability to understand and follow study requirements.
•Participant who is willing to receive reminders of appointments and videos reminding them on the brushing instructions.
•Participant must have a self-reported history of tooth sensitivity lasting more than 6 months but not more than 10 years and experience DH symptoms at least 'once a week' or more frequently.
•Participant must be in general oral health, with a minimum of 20 natural teeth.

Exclusion Criteria

•Participant who is an employee of the study site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the study site otherwise supervised by the investigator; or a sponsor employee directly involved in the conduct of the study or a member of their immediate family.
•Participant who is participating in, or has participated in, other studies (including nonmedicinal studies) involving investigational product(s) within 8 weeks of Screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
•Participant who is participating in, or has participated in, a study evaluating a tooth desensitizing treatment within 8 weeks of Screening (Visit 1).
•Participant who is using or has used an oral care product indicated for DH relief within 8 weeks of Screening (Visit 1).
•Participant who has had a professional desensitizing treatment within 8 weeks of Screening (Visit 1).
•Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
•Participant who is unwilling or unable to comply with product usage instructions or Lifestyle Considerations as described in the protocol.
•Participant who habitually rinses with water during toothbrushing (self-reported at Screening (Visit 1), or those observed to rinse with water while brushing during the supervised brushing with the allocated toothpaste at screening (Visit 1) or baseline (Visit 2).
•Female participant who is pregnant or intending to become pregnant during the study (self-reported) or is breastfeeding.
•Participant with a recent history (within the last year) of alcohol and/or substance abuse.
+27 more criteria

Locations (1)

West China School/Hospital of Stomatology, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

January 16, 2026

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

January 30, 2026

Enrollment

100

ESTIMATED participants

Conditions

Dentin Sensitivity

Interventions

Test toothpaste

DRUG

Sodium fluoride toothpaste

DRUG

Contacts

Haleon Response Center

CONTACT

+441932959500 ww.clinical-trial-register@haleon.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

Inclusion Criteria

Exclusion Criteria

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