In Situ Caries Model of Fluoride Toothpastes
Condition: Caries
Intervention: Sodium Fluoride Toothpaste; Amine Fluoride Toothpaste; Sodium monofluorophosphate/Sodium Fluoride Toothpaste; Placebo; 675 ppmf toothpaste
Intervention description: Test product; Test product; test product; placebo and washout treatment; dose response
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: remineralization; enamel; in situ; fluoride; caries

Summary:

      This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial
      caries lesions in an in situ model
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent: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

          -  Age:Aged 18 to 80 years inclusive

          -  Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions

          -  General Health:Good general health with (in the opinion of the investigator) no
             clinically significant and/or relevant abnormalities of medical history or oral
             examination that could interfere with subject safety during the study period

          -  Residency: Currently living in the Indianapolis, Indiana area

          -  Dentures: a) Currently wearing a removable mandibular partial denture with sufficient
             room in the posterior buccal flange area to accommodate two enamel specimens (required
             dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable
             partial dentures 24 hours per day during each two week treatment period. c) All
             restorations in a good state of repair

          -  Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated
             whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥
             0.8 mL/minute).

        Exclusion Criteria:

          -  Pregnancy:Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study

          -  Breast-feeding: Women who are breast-feeding

          -  Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients

          -  Clinical Study/Experimental Medication: a. Participation in another clinical study or
             receipt of an investigational drug within 30 days of the first treatment visit, with
             the exception of study GSK dental studies where the wash in period prior to treatment
             is sufficient. b. Previous participation in this study

          -  Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks
             prior to the screening visit

          -  Fluoride: Prescribed or professionally recommended use of fluoride supplements or
             fluoride mouthrinse

          -  Substance abuse: Recent history (within last year) of alcohol or other substance abuse

          -  Dental Health: Current active caries or periodontal disease that may compromise the
             study or health of the subjects

          -  Personnel: a. A member of the site study staff who is directly working on the project
             or living in that staff's household. b. An employee of the sponsor c. Any employee of
             any toothpaste manufacturer or their spouse or family member