Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Condition: Caries
Intervention: 0 ppm F; 250 ppm F as MFP; 1100 ppm as MFP; 2800 ppm F as MFP; 1100 ppm SnF2
Intervention description: Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be assigned to this treatment during the fifth period for this crossover study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the fluoride dose response of different dentifrice
      fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate
      (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between 18 and 85 years of age;

          -  Provide written informed consent prior to participation and be given a signed copy of
             the informed consent form;

          -  Be in general good health as determined by the Investigator based on a review of the
             health history/update for participation in the trial;

          -  Be wearing a removable mandibular partial denture with sufficient room in one
             posterior buccal flange area to accommodate two 4 mm round enamel specimens and room
             on the same side to accommodate two 4 mm round specimens in the buccal surface of two
             posterior denture teeth;

          -  Be willing and capable of wearing their removable partial denture 24 hours a day for
             four (4), three-week treatment periods;

          -  Be willing to allow study personnel to drill specimen sites (as described in #iv) in
             their mandibular partial denture;

          -  Be in good medical and dental health with no active caries or periodontal disease
             (NOTE: subjects presenting at screening with caries may continue in the study if their
             carious lesions are restored prior to beginning treatment 1);

          -  Have a salivary flow rate in the range of normal values (unstimulated whole saliva
             flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

        Exclusion Criteria:

          -  Currently being pregnant, intending to become pregnant during the study period, or
             breast feeding;

          -  Currently having any medical condition that could be expected to interfere with the
             subject's safety during the study period;

          -  Currently taking antibiotics or having taken antibiotics in the two weeks prior to
             beginning treatment 1;

          -  Having participated in another clinical study or receipt of an investigational drug
             within 30 days of beginning treatment 1; or

          -  Taking fluoride supplements, required to use a fluoride mouth rinse, or have received
             a professional fluoride treatment in the two weeks preceding specimen placement;

          -  Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and
             Boniva) for the treatment of osteoporosis.