Loading clinical trials...

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

COMPLETEDPHASE3

Investigating 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

NCT02832375•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This single center, 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 compared with a standard fluoride dentifrice.

Detailed Description

This will be a single center, three day, randomized, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Demonstrates understanding of the study 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
•Understands and is willing, able and likely to comply with all study procedures and restrictions
•Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant, relevant abnormalities of medical history or oral examination and 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 DH lasting more than six months but not more than 10 years at screening
•Minimum of 20 natural teeth at screening
•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) Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of less than or equal to (≤)1 and Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y\[Yes\]/N\[No\] response) screening
•Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars),that meet all of the following criteria at Baseline: Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2)

Exclusion Criteria

•Women who are known to be pregnant. Females of child bearing potential who have a positive urine pregnancy test or who are breast feeding
•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
•An employee of the sponsor or the study site or members of their immediate family
•Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or Any condition which, in the opinion of the investigator, causes 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 and 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
•Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
•Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the Investigator
+3 more criteria

Locations (1)

GSK Investigational Site

Las Vegas, Nevada, United States

Key Dates

Start Date

March 1, 2016

Primary Completion Date

May 1, 2016

Completion Date

May 12, 2016

Last Updated

May 25, 2017

Enrollment

242

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

stannous fluoride

DRUG

sodium monofluorophosphate

DRUG

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

NCT07352956

Dentin Sensitivity

View study

COMPLETEDNA

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

NCT06378255

Dentin Sensitivity

View study

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 25, 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.

View ClinicalTrials.gov Terms and Conditions

Investigating 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