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Evaluation of the Fluoride Dose Response of a Modified In Situ Caries Model

NCT03383783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-05-20

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, 500 and 1100 ppm fluoride of our existing in situ model involving the use of human enamel specimens placed in the buccal flange area of the subjects partial denture with the modified model involving placement of bovine enamel specimens in a denture tooth location.

Conditions

  • Caries

Interventions

DRUG

0 ppm F (placebo, negative control)

Each subject will use this product during one of the four treatment periods in the crossover study design.

DRUG

250 ppm F as NaF (dose-response control)

Each subject will use this product during one of the four treatment periods in the crossover study design.

DRUG

500 ppm F as NaF (dose-response control)

Each subject will use this product during one of the four treatment periods in the crossover study design.

DRUG

1100 ppm F as NaF (positive control)

Each subject will use this product during one of the four treatment periods in the crossover study design.

Sponsors & Collaborators

Principal Investigators

  • Domenick T Zero, DDS, MS · Indiana University

  • Anderson Hara, DDS, PhD · Indiana University

  • Frank Lippert, PhD · Indiana University

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
2017-12-19
Primary Completion
2018-05-02
Completion
2018-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03383783 on ClinicalTrials.gov