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Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

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

NCT02773758•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

Eligibility

Age

18 - 65 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.
•Aged 18-65 years inclusive.
•Good general and mental health with:
•No clinically significant and relevant abnormalities of medical history or oral examination.
•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.
•Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
•Minimum of 20 natural teeth.
•Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
•Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
•Tooth with signs of sensitivity measured by qualifying evaporative air assessment (yes\[Y\]/No\[N\] response).
+2 more criteria

Exclusion Criteria

•Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
•Previous participation in this study or 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.
•Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
•Dental prophylaxis within 4 weeks of Screening.
•Tongue or lip piercing or presence of dental implants.
•Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
•Teeth bleaching within 8 weeks of Screening.
•Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
+7 more criteria

Locations (1)

GSK Investigational Site

Mississauga, Ontario, Canada

Key Dates

Start Date

January 1, 2016

Primary Completion Date

March 11, 2016

Completion Date

March 11, 2016

Last Updated

September 29, 2017

Enrollment

143

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

Stannous Fluoride Dentifrice

OTHER

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

NCT07352956

Dentin Sensitivity

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COMPLETEDNA

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

NCT06378255

Dentin Sensitivity

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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: September 29, 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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Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine 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