Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model
Condition: Caries
Intervention: 0 ppm F (placebo, negative control); 250 ppm F as NaF (dose-response control); 500 ppm F as NaF (dose-response control); 1100 ppm F as NaF (positive control)
Intervention description: Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.; Each subject will use this product during one of the four treatment periods in the crossover study design.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Caries

Summary:

      The purpose of this study is to evaluate the fluoride dose response of different dentifrice
      fluoride concentrations - 0, 250, 500 and 1100 ppm fluoride of our existing in situ model
      involving the use of human enamel specimens placed in the buccal flange area of the subjects
      partial denture with the modified model involving placement of bovine enamel specimens in a
      denture tooth location.
    

Eligibility criteria:

        Inclusion Criteria:

          1. provide voluntary, written informed consent;

          2. be between 18 and 85 years old;

          3. understand and be willing, able and likely to comply with all study procedures and
             restrictions;

          4. be wearing a removable mandibular partial denture with sufficient room in one
             posterior buccal flange area to accommodate two enamel specimens (required dimensions
             12 × 7 mm) and room on the same side to accommodate two 4 mm round specimens in the
             buccal surface of two posterior denture teeth;

          5. be willing and capable of wearing their removable partial denture 24 hours a day for
             four (4), two-week treatment periods;

          6. be willing to allow study personnel to drill specimen sites (as described #4) in their
             mandibular partial denture;

          7. 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.

          8. 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:

          1. currently be pregnant, intending to become pregnant during the study period or breast
             feeding;

          2. currently have any medical condition that could be expected to interfere with the
             subject's safety during the study period;

          3. currently be taking antibiotics or have taken antibiotics in the two weeks prior to
             the beginning treatment 1;

          4. have participated in another clinical study or receipt of an investigational drug
             within 30 days of beginning treatment 1; or

          5. be taking fluoride supplements, required to use a fluoride mouthrinse or have received
             a professional fluoride treatment in the two weeks preceding specimen placement;

          6. be taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva)
             for the treatment of osteoporosis;