Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Status and phase
Completed
Phase 4
Conditions
Caries
Treatments
Drug: 250 ppm F as MFP
Drug: 2800 ppm F as MFP
Drug: 1100 ppm as MFP
Drug: 1100 ppm SnF2
Drug: 0 ppm F
Details and patient eligibility
About
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 leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
Enrollment
15 patients
Sex
All
Ages
18 to 85 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
15 participants in 5 patient groups
Period 1
Other group
Description:
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Treatment:
Drug: 0 ppm F
Drug: 250 ppm F as MFP
Drug: 2800 ppm F as MFP
Drug: 1100 ppm as MFP
Period 2
Other group
Description:
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Treatment:
Drug: 0 ppm F
Drug: 250 ppm F as MFP
Drug: 2800 ppm F as MFP
Drug: 1100 ppm as MFP
Period 3
Other group
Description:
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Treatment:
Drug: 0 ppm F
Drug: 250 ppm F as MFP
Drug: 2800 ppm F as MFP
Drug: 1100 ppm as MFP
Period 4
Other group
Description:
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Treatment:
Drug: 0 ppm F
Drug: 250 ppm F as MFP
Drug: 2800 ppm F as MFP
Drug: 1100 ppm as MFP
Period 5
Other group
Description:
1100 ppm SnF2 toothpaste only
Treatment:
Drug: 1100 ppm SnF2
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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