In Situ Caries of Fluoride Toothpastes
Condition: Healthy Subjects; Partial Denture Wearers; Caries
Intervention: Sodium fluoride toothpaste; Placebo toothpaste
Intervention description: Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F; Fluoride free toothpaste (0 ppm F)
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: remineralization; enamel; fluoride; caries; in situ

Summary:

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

Eligibility criteria:

        Inclusion Criteria

          1. 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.

          2. Age:Aged between 18 and 78 years.

          3. Compliance:Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

          4. 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.

          5. Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated
             community (1 ppm F). ii. 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). iii. Willing and capable of
             wearing their removable partial dentures 24 hours per day during each two week
             treatment period. iv.All restorations in a good state of repair.

          6. 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

          1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study. No pregnancy test will be required.

          2. Breast-feeding:Women who are breast-feeding.

          3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          4. Clinical Study/Experimental Medication:Participation in another clinical study or
             receipt of an investigational drug within 30 days of the first treatment visit, with
             the exception of study T3157495 where the wash in period prior to treatment is
             sufficient.

          5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks
             prior to the screening visit.

          6. Fluoride:Taking fluoride supplements for medical reasons.

          7. Dental Health: Current active caries or periodontal disease that may compromise the
             study or health of the subjects.

          8. Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any
             employee of any toothpaste manufacturer or their spouse or family member.