In Situ Caries Efficacy of Fluoride Toothpastes
Condition: Caries
Intervention: NaF; Placebo; NaMFP
Intervention description: Fluoride; Placebo; Fluoride
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fluoride; in situ; remineralization; enamel; caries

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:

          -  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 between 18 and 80 years.

          -  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 relevant abnormalities of medical history or physical
             examination.

          -  Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride
             supplements for medical reasons

          -  Dentures: a)Currently wearing a removable mandibular partial denture with sufficient
             room in both posterior buccal flange areas to accommodate two enamel specimens on each
             side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side.
             b) Willing to have their denture modified to accommodate enamel test specimens and
             willing and capable of wearing their removable mandibular partial dentures 24 hours
             per day during the experimental periods

          -  Dental health: Have no current active caries or periodontal disease that may
             compromise the study or the health of the subjects and 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 milliliter (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.

          -  Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks
             prior to the screening visit

          -  Clinical Study/Experimental Medication: a) Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit.b)
             Participation in another GSKCH investigational dental product study within 7 days of
             first study treatment c)Previous participation in this study.

          -  Substance abuse: Recent history (within the last year) of alcohol or other substance
             abuse.

          -  Personnel:a) A member of the site study staff living in same household.b)An employee
             of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or
             family member