In Situ Caries of Fluoride Toothpastes

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

• Healthy Volunteers
• Partial Denture Wearers

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

   1. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F).
   2. 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)).
   3. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period.
   4. 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

   1. A member of the site study staff
   2. An employee of the sponsor
   3. Any employee of any toothpaste manufacturer or their spouse or family member.