Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

GlaxoSmithKline118 enrolled

Overview

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

118

Conditions

Dentinal Sensitivity Hypersensitivity

Interventions

Test ToothpasteDRUG

0.454% stannous fluoride toothpaste

Negative Control ToothpasteDRUG

0.76% sodium monofluorophosphate toothpaste

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion: * Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years * Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. * Teeth having a gingival index score of less than or equal to 1 * Teeth with a clinical mobility less than or equal to 1 * sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2). Exclusion: * Presence of chronic debilitating disease which could affect study outcomes. * Any condition which causes xerostomia. * Dental prophylaxis within 4 weeks of screening. * Tongue or lip piercing or presence of dental implants. * Professional desensitising treatment within 12 weeks of screening. * 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 12 weeks of screening. * Tooth with evidence of current or recent caries, or reported treatment of decay in 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, or not expected to respond to treatment with an over-the counter dentifrice. * Daily doses of a medication which could interfere with the perception of pain. * Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline. * Individuals who require antibiotic prophylaxis for dental procedures.

Locations (1)

BioSci Research America, Inc.

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment

Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.

Time frame: Baseline and immediately after treatment administration

Secondary Outcomes

Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3

Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.

Time frame: Baseline and Day 3

Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14

Time frame: Baseline and Day 14

Data from ClinicalTrials.gov

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