Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity
Condition: Dentin Hypersensitivity; Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Potassium Nitrate; Stannous Fluoride
Intervention description: The test dentifrice contains 5% w/w potassium nitrate.; The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
Intervention MeSH terms: Fluorides; Tin Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
Masking: Double (Investigator, Outcomes Assessor)
Masking description: Examiner-Blind
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This exploratory study will characterize the efficacy profile of an experimental dual active
      5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single
      active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant provision of a signed and dated informed consent document indicating that
             the participant has been informed of all pertinent aspects of the study before any
             assessment is performed

          -  Participant who is willing and able to comply with scheduled visits, treatment plan,
             and other study procedures

          -  Participant in good general, oral and mental health with, in the opinion of the
             investigator or medically qualified designee, no clinically significant/relevant
             abnormalities in medical history, or upon oral examination, or condition that would
             impact the Participant's safety, wellbeing or the outcome of the study, if they were
             to participate in the study, or affect the individual's ability to understand and
             follow study procedures and requirements

          -  Male participant able to father children or female participant of child-bearing
             potential and at risk for pregnancy must agree to use a highly effective method of
             contraception throughout the study and for at least 5 days after the last dose of
             assigned treatment

          -  AT VISIT 1 (Screening): Participant must have

               1. a self-reported history of dentin hypersensitivity (DH) lasting more than six
                  months but not more than 10 years

               2. a minimum of 20 natural teeth

               3. a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars),
                  preferably in different quadrants, with clinically diagnosed DH; each tooth must
                  meet the following criteria:

          -  exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)

          -  Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin)
             only

          -  Clinical mobility less than or equal to (=<) 1

          -  DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity
             (tactile threshold [=<] 20 gram (g); Schiff sensitivity score greater than or equal to
             [>=] 2)

          -  AT VISIT 2 (Baseline):

        Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines,
        pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile
        and evaporative air sensitivity (each tooth must have a tactile threshold (=<) 20 g and a
        Schiff sensitivity score (>=) 2) at the Screening and Baseline visits

        Exclusion Criteria:

          -  Participant who is an employee of the investigational site, either directly involved
             in the conduct of the study or a member of their immediate family; or an employee of
             the investigational site otherwise supervised by the investigator; or a
             GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct
             of the study or a member of their immediate family

          -  Participant who has participated in other studies (including non-medicinal studies)
             involving investigational product(s) within 30 days prior to study entry and/or during
             study participation

          -  Participant with, in the opinion of the investigator or medically qualified designee,
             an acute or chronic medical, oral, psychiatric condition or laboratory abnormality
             that may increase the risk associated with study participation or investigational
             product administration or may interfere with the interpretation of study results and,
             in the judgment of the investigator or medically qualified designee, would make the
             participant inappropriate for entry into this study

          -  Participant with any condition which, in the opinion of the investigator or medically
             qualified designee, causes xerostomia

          -  Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test
             [UPT] at Screening)

          -  Participant who is a breast-feeding female

          -  Participant with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients

          -  Participant with a recent history (within the last year) of alcohol or other substance
             abuse

          -  Participant who has participated in another tooth desensitizing treatment study within
             8 weeks Screening

          -  Participant who has used an oral care product indicated for the relief of DH within 8
             weeks of Screening (participant will be required to bring their current oral care
             products to the site in order to verify the absence of known anti-sensitivity
             ingredients)

          -  Participant who has had dental prophylaxis within 4 weeks of Screening

          -  Participant who has had a tooth bleaching procedure within 8 weeks of Screening

          -  Participant who has had treatment for periodontal disease (including surgery) within
             12 months of Screening

          -  Participant who has had scaling or root planning within 3 months of Screening

          -  Participant with gross periodontal disease

          -  Participant with evidence of gross intra-oral neglect or the need for extensive dental
             therapy

          -  Participant with a tongue or lip piercing or presence of multiple dental implants

          -  Participant with fixed or removable partial dentures

          -  Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic
             retainer

          -  SPECIFIC DENTITION EXCLUSIONS FOR 'TEST TEETH':

               1. Tooth with evidence of current or recent caries or reported treatment of decay
                  within 12 months of Screening

               2. Tooth with exposed dentin but with deep, defective or facial restorations

               3. Tooth with full crown or veneer

               4. Sensitive tooth with contributing etiologies other than erosion, abrasion or
                  recession to exposed dentin

               5. Sensitive tooth not expected to respond to treatment with an over-the-counter
                  dentifrice in the opinion of the investigator

          -  Participant taking daily doses of medication/treatments which, in the opinion of the
             investigator or medically qualified designee, could interfere with the perception of
             pain (examples of such medications include analgesics, anticonvulsants, antihistamines
             that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants,
             mood-altering and anti-inflammatory drugs)

          -  AT VISIT 1 (Screening):

        Participant who has taken antibiotics in the 2 weeks prior to the Screening visit

        - AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the
        Baseline visit, during the acclimatization period

          -  Participant taking daily doses of a medication which, in the opinion of the
             investigator or medically qualified designee, is causing xerostomia

          -  Participant who requires antibiotic prophylaxis for dental procedures

          -  Participant who has previously been enrolled in this study

          -  Participant who, in the opinion of the investigator or medically qualified designee,
             should not participate in the study