The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Dentine Hypersensitivity

Treatments

Drug: Sodium Monofluorophosphate

Drug: Stannous Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT03072719

RH01327 (Other Identifier)

202161

Details and patient eligibility

About

A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

Demonstrates understanding of the study and willingness to participate
Aged at least 18 to 65 years
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

Exclusion

Pregnant or breast-feeding women
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 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.
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
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
Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
Individuals who require antibiotic prophylaxis for dental procedures
Any participant who, in the judgment of the investigator, should not participate in the study.