CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
0 ppm F (placebo, negative control) +3 moredrug
Likely dose
Not stated in 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/NCT03383783
NCT03383783Phase 3Completed

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

Domenick Zero·interventional·Posted Dec 26, 2017·Updated May 20, 2019

In Brief

A Phase 3 clinical trial evaluating 0 ppm F (placebo, negative control), 250 ppm F as NaF (dose-response control), and 2 other interventions for Caries. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaries
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartDec 19, 2017
Primary CompletionMay 2, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.5 years ago

Interventions

0 ppm F (placebo, negative control)drug

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

250 ppm F as NaF (dose-response control)drug

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

500 ppm F as NaF (dose-response control)drug

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

1100 ppm F as NaF (positive control)drug

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