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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Dentinal Sensitivity

Hypersensitivity

Treatments

Drug: Negative Control Toothpaste

Drug: Test Toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT01494649

Z7871335

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.