Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

Topical fluorides in a wide variety of delivery systems have been proven to be clinically
effective in the prevention of dental caries. It is generally agreed that fluoride has its
anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the
rate of enamel remineralization. There is a general consensus that level of fluoride in
plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride
levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to
the diluting and washing effect of saliva followed by periodic swallowing. To evaluate
fluoride content, plaque samples will be collected from the interproximal surfaces of the
posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be
calculated using a micro analytical method and in comparison to a standard fluoride curve
constructed on the same day of the analysis.

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.