A Phase 1 interventional study of 0 ppm F and 250 ppm F as MFP in Caries, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Procter and Gamble · Phase 1, Interventional, and Basic science
This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography
Exclusion Criteria:
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)
Drug: 0 ppm F · Drug: 250 ppm F as MFP · Drug: 1100 ppm as MFP · Drug: 2800 ppm F as MFP
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)
Drug: 0 ppm F · Drug: 250 ppm F as MFP · Drug: 1100 ppm as MFP · Drug: 2800 ppm F as MFP
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)
Drug: 0 ppm F · Drug: 250 ppm F as MFP · Drug: 1100 ppm as MFP · Drug: 2800 ppm F as MFP
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)
Drug: 0 ppm F · Drug: 250 ppm F as MFP · Drug: 1100 ppm as MFP · Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
area under the curve (AUC)
The primary endpoint will be AUC of the fluoride levels from 2 to 30 minutes. AUC will be calculated for each subject and treatment combination by integrating a 3 parameter first order decay model curve estimate (y= theta1 \* exp (-theta2.X) + theta3). For any values obtained for a timepoint that are below the detection limit, 0.5 times the detection limit will be used. The following rules will apply if a subject has missing value(s) before the AUC is calculated: * If 2 or more timepoints are missing within a period, then the AUC will be set to missing * If only 2-minute data are missing, then curve will be estimated as above * If 6-minute or 12-minute data are missing, a linear imputation between the adjacent timepoints will be used * If 30-minute data are missing, the 12-minute data will be carried forward.
Time frame: 2-minutes, 6-minutes, 12-minutes, and 30-minutes
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Procter and Gamble