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An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy

NCT01665911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-02-23

Study results available
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Summary

The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.

Conditions

  • Caries

Interventions

DRUG

1.5 mg Sodium Fluoride in 100 ml milk

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

DRUG

1.5 mg sodium fluoride in 200 ml milk

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

DRUG

3 mg sodium fluoride in 100 ml milk

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

DRUG

3 mg sodium fluoride in 200 ml milk

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

OTHER

Non-fluoridated milk, 200 ml

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

Sponsors & Collaborators

  • The Borrow Foundation

    collaborator UNKNOWN

  • Frank Lippert

    lead OTHER

Principal Investigators

  • Frank Lippert, PhD · Indiana University

  • Domenick Zero, DDS, MS · Indiana University

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-06-30

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 NCT01665911 on ClinicalTrials.gov