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Evaluation of the Fluoride Dose Response Using In Situ Caries Model

NCT04763044 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-07-19

Study results available
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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

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.

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-07-21
Completion
2021-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763044 on ClinicalTrials.gov