Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Dentinal Hypersensitivity

Treatments: Drug: Sodium monofluorophosphate dentifrice; Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; Drug: Sodium Fluoride dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT01831817

RH01591

Details and patient eligibility

About

The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Full description

This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

Enrollment: 140 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
• Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.

Exclusion criteria

• Specific Dentition Exclusions for Test teeth

  1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
  2. Tooth with exposed dentin 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 etiologies other than erosion, abrasion or recession of exposed dentin.
  3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator

• Use of a sensitivity dentifrice within 8 weeks of screening

• Individuals who require antibiotic prophylaxis for dental procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 4 patient groups

5% calcium sodium phosphosilicate/ sodium monofluorophosphate

Experimental group

Description:

Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Treatment:

Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

0% calcium sodium phosphosilicate/sodium monofluorophosphate

Active Comparator group

Description:

Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate

Treatment:

Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice

Sodium monofluorophosphate

Active Comparator group

Description:

Dentifrice containing 1000 ppmF as sodium monofluorophosphate

Treatment:

Drug: Sodium monofluorophosphate dentifrice

Sodium fluoride

Active Comparator group

Description:

Dentifrice containing 1100 ppmF as sodium fluoride

Treatment:

Drug: Sodium Fluoride dentifrice