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Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity

NCT03943095•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

Detailed Description

This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
•Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
•Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements
•Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
•AT VISIT 1 (Screening): Participant must have
•1. a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years
•2. a minimum of 20 natural teeth
•3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically diagnosed DH; each tooth must meet the following criteria:
•exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)
•Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin) only
+4 more criteria

Exclusion Criteria

•Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
•Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
•Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
•Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
•Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test \[UPT\] at Screening)
•Participant who is a breast-feeding female
•Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
•Participant with a recent history (within the last year) of alcohol or other substance abuse
•Participant who has participated in another tooth desensitizing treatment study within 8 weeks Screening
•Participant who has used an oral care product indicated for the relief of DH within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
+23 more criteria

Locations (1)

GSK Investigational Site

Mississauga, Canada

Key Dates

Start Date

May 13, 2019

Primary Completion Date

August 28, 2019

Completion Date

August 28, 2019

Last Updated

September 11, 2020

Enrollment

123

ACTUAL participants

Conditions

Dentin HypersensitivityDentin Sensitivity

Interventions

Potassium Nitrate

OTHER

Stannous Fluoride

OTHER

Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

NCT07069127

Celiac DiseaseDentin Hypersensitivity+1 more

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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

NCT07352956

Dentin Sensitivity

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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: September 11, 2020Data 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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Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

Inclusion Criteria

Exclusion Criteria

Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients

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

Validation of a French Version of the DHEQ

Diode Laser Plus CPP-ACPF vs CPP-ACPF Alone for Dentin Hypersensitivity

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

Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity