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% w/w stannous fluoride containing 1100ppm of fluoride; 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This single center, 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 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: No clinically significant, relevant abnormalities of medical
             history or oral examination and 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 DH lasting more than six months but not more than 10 years at
             screening

          -  Minimum of 20 natural teeth at screening

          -  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 less than or equal to (≤)1 and Tooth with signs of sensitivity measured by
             qualifying evaporative air assessment (Y[Yes]/N[No] response) screening

          -  Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars),that
             meet all of the following criteria at Baseline: 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. Females of child bearing potential who have a
             positive urine pregnancy test or who are breast feeding

          -  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

          -  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, 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

          -  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, tranquilizers, 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