Status:
COMPLETED
Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Lead Sponsor:
Procter and Gamble
Conditions:
Caries
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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) and a fifth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04763044
Start Date
March 1 2021
End Date
July 21 2021
Last Update
July 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oral Health Research Institute
Indianapolis, Indiana, United States, 46202