Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice; 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice; Sodium monofluorophosphate dentifrice; Sodium fluoride dentifrice
Intervention description: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate; Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate; Dentifrice containing 1000 ppmF as sodium monofluorophosphate; Dentifrice containing 1100 ppmF 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: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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:

          1. 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

          2. 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:

          1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study.

          2. Breast-feeding: Women who are breast-feeding.

          3. Medical History: a) Chronic debilitating disease is present b) Chronic disease or
             other condition is present that is associated with intermittent episodes or constant
             daily pain, such as arthritis, low back pain, dysmenorrhea, etc.

          4. Medications: Daily doses of medication, which in the opinion of the investigator,
             might interfere with the perception of pain, are being taken. Examples of such
             medications include analgesics, anticonvulsants, antihistamines that cause marked or
             moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory
             drugs.

          5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an
             over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed
             dentine but with deep, defective or facial restorations, teeth used as abutments for
             fixed or removable partial dentures, teeth with full crowns, orthodontic bands,
             extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other
             than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene
             (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic
             therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip
             or tongue piercings. f) Periodontal surgical history within the past 6 months or have
             been scaled /root planed within the past 3 months.

          6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          7. Clinical Study/Experimental Medication: a) Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit b) Previous
             participation in this study.

          8. Other: Any subject who in the opinion of the investigator, should not participate in
             the study.