NCT04763044

Evaluation of the Fluoride Dose Response Using In Situ Caries Model

Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caries

Interventions

Type	Name	Description
DRUG	0 ppm F	Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
DRUG	250 ppm F as MFP	Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
DRUG	1100 ppm as MFP	Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
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.
DRUG	1100 ppm SnF2	Each subject will be assigned to this treatment during the fifth period for this crossover study.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2021-02-21
• Last updated: 2022-07-19
• Results posted: 2022-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study