Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Stannous Fluoride Dentifrice; Sodium monofluorophosphate Dentifrice
Intervention description: Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride); Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This will be a single centre, two week, randomised, examiner blind, two treatment arm,
      parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected
      test teeth), controlled study, in participant with at least two sensitive teeth that meet the
      study criteria at the Screening and Baseline visits. The study will be conducted in
      participants in good general health, with pre-existing self-reported and clinically diagnosed
      tooth sensitivity at screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Demonstrates understanding of the study procedures, restrictions and willingness to
             participate as evidenced by voluntary written informed consent and has received a
             signed and dated copy of the informed consent form.

          -  Aged 18-65 years inclusive.

          -  Good general and mental health with:

        No clinically significant and relevant abnormalities of medical history or oral
        examination.

        Absence of any condition that would impact on the participant's safety or wellbeing or
        affect the individual's ability to understand and follow study procedures and requirements.

          -  Self-reported history of dentinal hypersensitivity (DH) lasting more than six months
             but not more than 10 years.

          -  Minimum of 20 natural teeth.

          -  Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably
             in different quadrants, that meet all of the following criteria at screening: Signs of
             facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).

        Tooth with MGI score =0 adjacent to the test area (exposed dentine) only and a clinical
        mobility of ≤1.

        Tooth with signs of sensitivity measured by qualifying evaporative air assessment
        (yes[Y]/No[N] response).

          -  Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that
             meet all of the following criteria at screening:

        Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus
        (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

        Exclusion Criteria:

          -  Women who are breast-feeding, known to be pregnant or who are intending to become
             pregnant over the duration of the study.

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Previous participation in this study or participation in another clinical study
             (including cosmetic studies) 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.

          -  Presence of chronic debilitating disease which, in the opinion of the investigator,
             could affect study outcomes or causing xerostomia.

          -  Dental prophylaxis within 4 weeks of Screening.

          -  Tongue or lip piercing or presence of dental implants.

          -  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 8 weeks of Screening.

          -  Tooth with evidence of current or recent caries, or reported treatment of decay within
             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.

          -  Use of an oral care product indicated for the relief of dentine hypersensitivity
             within 8 weeks of screening.

          -  Daily doses of medication/treatments which, in the opinion of the investigator, could
             interfere with the perception of pain.

        Examples of such medications include analgesics, anticonvulsants, antihistamines that cause
        marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and
        anti-inflammatory drugs.

          -  Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.

          -  Daily dose of a medication which, in the opinion of the Investigator, is causing
             xerostomia.