Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Sodium Fluoride (NaF); Placebo
Intervention description: Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF; Fluoride free toothpaste (0ppmF)
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: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: toothpaste; plaque fluid; fluoride

Summary:

      The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF)
      containing toothpastes in prevention of dental caries. Change from baseline fluoride data at
      various time points up to four hours after a single brushing with NaF containing toothpastes
      will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age:Age 18 through 65 years.

          2. 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, specifically including diabetes or hypoglycemia.

          3. Compliance: Understands and is willing, able and likely to comply with all study
             procedures and restrictions.

          4. 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.

          5. Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride
             supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2
             ml/min) salivary flow rate. c) Have a full complement of natural teeth with the
             exception of third molars and teeth extracted for orthodontic reasons. Participants
             natural teeth must have at least one surface free of restoration in each interproximal
             embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.

        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. Medical History:Current or relevant history of any serious, severe or unstable
             physical or psychiatric illness that would make the subject unlikely to fully complete
             the study or any that increases the risk to the subject.

          4. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          5. Clinical Study/Experimental Medication:Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit 1 at the
             start of the study with the exception of those participating in GSKCH study Z3170476.

          6. Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks
             prior to any treatment visit or during the study. b) Has a medical condition that
             would require prophylactic antibiotics prior to a dental cleaning.

          7. Dental: a) Current active caries or moderate to severe periodontal disease that may
             compromise the health of the participants or the study. b) Current use of
             chlorhexidine mouthrinse.

          8. Personnel: An employee of the sponsor or the study site who is directly involved in
             the conduct of the study.