Phase 4
N=15
Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Caries
Bottom Line
View on ClinicalTrials.gov: NCT04763044 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Enamel Fluoride Uptake (EFU) — 2.28; 4.51; 8.78; 14.05 μg F/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0 ppm F (Drug); 250 ppm F as MFP (Drug); 1100 ppm as MFP (Drug); 2800 ppm F as MFP (Drug); 1100 ppm SnF2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enamel Fluoride Uptake (EFU) |
3.86; 7.23; 11.53; 18.92; 12.65 | — |
| SECONDARY Enamel Fluoride Uptake (EFU) |
3.86; 7.23; 11.53; 18.92; 12.65 | — |
| SECONDARY Percent Surface Microhardness (SMH) |
4.76; 11.14; 17.51; 33.38; 17.91 | — |
| SECONDARY Enamel Fluoride Uptake (EFU) |
3.86; 7.23; 11.53; 18.92; 12.65 | — |
| SECONDARY Percent Surface Microhardness (SMH) |
4.76; 11.14; 17.51; 33.38; 17.91 | — |
| SECONDARY Percent Surface Microhardness (SMH) |
4.76; 11.14; 17.51; 33.38; 17.91 | — |
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 leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04763044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.