Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Intervention: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; Sodium monofluorophosphate dentifrice; Sodium Fluoride dentifrice
Intervention description: Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate; No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate; Sodium monofluorophospate dentifrice (1000 ppm F); Dentifrice containing 1100ppm F as sodium fluoride
Intervention MeSH terms: Calcium, Dietary; Listerine; Calcium; Fluorides; Sodium Fluoride; Fluorophosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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