To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Stannous fluoride; Sodium monofluorophosphate
Intervention description: 0.454% weight by weight (w/w) stannous fluoride containing 1100 parts per million (ppm) fluoride; 0.76% w/w sodium monofluorophosphate containing 1000 ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This single centre study will be used to investigate the efficacy of an experimental stannous
      fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term
      use compared with a standard fluoride dentifrice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Demonstrates understanding of the study 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.

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee: No clinically significant and relevant abnormalities of medical
             history or oral examination and absence of any condition that would impact on the
             participants safety or wellbeing or affect the individual's ability to understand and
             follow study procedures and requirements.

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions.

          -  At Visit 1 (Screening): 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: 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 (Y/N response)

          -  At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth
             (incisors, canines, pre-molars), that meet all of the following criteria: Tooth with
             signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and
             evaporative air assessment (Schiff sensitivity score ≥ 2)

        Exclusion Criteria:

          -  A woman who is known to be pregnant or who are intending to become pregnant over the
             duration of the study.

          -  A woman who is breast-feeding.

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients.

          -  Participation in another clinical study (including cosmetic studies) or receipt of an
             investigational drug within 30 days of the screening visit, previous participation in
             this study and any participant who was randomised for inclusion in study 205710

          -  Recent history (within the last year) of alcohol or other substance abuse.

          -  An employee of the sponsor or the study site or members of their immediate family.

          -  Presence of chronic debilitating disease which, in the opinion of the investigator,
             could affect study outcomes and any condition which, in the opinion of the
             investigator, causes xerostomia.

          -  Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing
             treatment within 8 weeks of Screening (professional sensitivity treatments and
             non-dentifrice sensitivity treatments), Gross periodontal disease, treatment of
             periodontal disease (including surgery) within 12 months of Screening, scaling or root
             planning within 3 months of screening and vital 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, dental
             implants, 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 and sensitive tooth not expected to respond to treatment
             with an over-the-counter dentifrice in the opinion of the investigator.

          -  Use of an oral care product indicated for the relief of dentine hypersensitivity
             within 8 weeks of screening (participants will be required to bring their current oral
             care products to the site in order to verify the absence of known anti-sensitivity
             ingredients).

          -  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 andanti-inflammatory drugs,
             currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and
             daily dose of a medication which, in the opinion of the investigator, is causing
             xerostomia.

          -  Any participant who, in the judgment of the investigator, should not participate in
             the study.