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The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity | Clinical Trials | Clareo Health

COMPLETEDNA

The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

NCT02612064•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This single centre, dual site, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
•Good general and mental health with, in the opinion of the investigator or medically qualified designee:
•A. No clinically significant and relevant abnormalities in medical history or upon oral examination.
•B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
•\- Dental health
•At Screening:
•A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
•B. Good general oral health, with a minimum of 20 natural teeth.
•C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:
•Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
+5 more criteria

Exclusion Criteria

•Pregnant or breast feeding women
•Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
•Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
•Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
•Any condition which, in the opinion of the investigator, causes xerostomia.
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
•Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
•Recent history (within the last year) of alcohol or other substance abuse
•Dental prophylaxis within four weeks of Screening.
•Tongue or lip piercing or presence of dental implants.
+8 more criteria

Locations (2)

GSK Investigational Site

Ellesmere Port, Cheshire, United Kingdom

GSK Investigational Site

Metropolitan Borough of Wirral, United Kingdom

Key Dates

Start Date

November 1, 2015

Primary Completion Date

June 3, 2016

Completion Date

June 3, 2016

Last Updated

May 17, 2017

Enrollment

488

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

Stannous Fluoride dentifice

DEVICE

Sodium Monofluorophosphate dentifrice

OTHER

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

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COMPLETEDNA

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

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COMPLETEDPHASE1/PHASE2

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

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: May 17, 2017Data 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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The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

Inclusion Criteria

Exclusion Criteria

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

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Efficacy and Safety Assessment of Experimental Bleaching Agents

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

Propolis in Reducing Dentin Hypersensitivity