Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluorides; Sodium Fluoride

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