CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
1.5 mg Sodium Fluoride in 100 ml milk +4 moredrug
Likely dose
1.5 mg Sodium Fluoride in 100 ml milkfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01665911
NCT01665911N/ACompleted
CompareCT.gov

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

Frank Lippert·interventional·Posted Aug 16, 2012·Updated Feb 23, 2015

In Brief

A clinical study evaluating 1.5 mg Sodium Fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, and 3 other interventions for Caries. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaries
CountriesUnited States
CollaboratorsThe Borrow Foundation

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.9 years ago

Interventions

1.5 mg Sodium Fluoride in 100 ml milkdrug

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

1.5 mg sodium fluoride in 200 ml milkdrug

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

3 mg sodium fluoride in 100 ml milkdrug

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

3 mg sodium fluoride in 200 ml milkdrug

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

Non-fluoridated milk, 200 mlother

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