Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
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 1100ppm fluoride; 0.76% w/w sodium monofluorophosphate containing 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: Single (Investigator)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This single centre, comparative design 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 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

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee: a) No clinically significant and relevant abnormalities of medical
             history or oral examination. b) 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: 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 [Lobene, 1986] and
             a clinical mobility of ≤1, Tooth with signs of sensitivity measured by qualifying
             evaporative air assessment (Y/N response)

          -  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:

          -  Women who are known to be pregnant or who are intending to become pregnant over the
             duration of the study

          -  Women who are 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

          -  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 or Any condition which, in the opinion of the
             investigator, causes xerostomia

          -  Dental prophylaxis within 4 weeks of Screening or 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 and
             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 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 and anti-inflammatory drugs

          -  Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline