Evaluation of the Fluoride Dose Response Using In Situ Caries Model

• Status: Completed
• Trial end date: 2021-07-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) using an in situ caries model.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Procter and Gamble

Criteria

Inclusion Criteria:

• Be between 18 and 85 years of age;

• Provide written informed consent prior to participation and be given a signed copy of the informed consent form;

• Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;

• Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;

• Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;

• Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;

• Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1);

• 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).

Exclusion Criteria:

• Currently being pregnant, intending to become pregnant during the study period, or breast feeding;

• Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;

• Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;

• Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or

• Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;

• Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.