Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model
Condition: Dental Erosion
MeSH terms: Tooth Erosion
Intervention: NaF/ KNO3/isopentane Dentifrice; NaF/KNO3 Dentifrice; NaF Dentifrice; Placebo Dentifrice
Intervention description: Experimental toothpaste; Experimental toothpaste; Active comparator; Placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: enamel fluoride uptake; erosion; enamel remineralization

Summary:

      The purpose of this study is to determine whether an experimental fluoridated dentifrice is
      effective in the treatment of dental caries
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: Aged between 18 and 78

          2. Fluoride: Currently living in the Indianapolis area which has a fluoridated water
             supply (1 ppm F) and not taking fluoride supplements for medical reasons

          3. Dentures: 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 mm). Willing and capable of wearing their removable partial dentures
             24 hours per day during the experimental periods

          4. Dental health:Have no current active caries or periodontal disease that may compromise
             the study or the health of the participants and all restorations in a good state of
             repair

          5. Salivary flow: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

          6. Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions

          7. 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

          8. 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 participant safety during the study period

        Exclusion Criteria:

          1. Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks
             prior to the screening visit

          2. Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients

          3. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant
             over the duration of the study.

          4. Breast-feeding:Women who are breast-feeding.

          5. Clinical Study/Experimental Medication: Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit

          6. Personnel:An employee of the sponsor or the study site who is directly involved in the
             study