CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
Low fluoride and conventional dentifrices with different pHother
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/NCT01049503
NCT01049503Phase 3Completed
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Effect of pH and Fluoride Concentration of Liquid Dentifrices on Caries Control in a Fluoridated Area: a Randomized Clinical Trial

University of Sao Paulo·interventional·Posted Jan 14, 2010·Updated Aug 30, 2012

In Brief

A Phase 3 clinical trial evaluating Low fluoride and conventional dentifrices with different pH for Dental Fluorosis and Dental Caries. Completed, enrolled 315 participants across 1 site.

Detailed Summary

This study aims to assess the overall effect of pH and fluoride concentration of liquid dentifrices in the control of children dental caries of a fluoridated area, through visual inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F concentration of a subsample of the children enrolled will be evaluated, in order to assess F bioavailability from these formulations and the evaluation of the concentration of fluoride incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Fluorosis, Dental Caries
CountriesBrazil
CollaboratorsFundação de Amparo à Pesquisa do Estado de São Paulo

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.5 years ago

Interventions

Low fluoride and conventional dentifrices with different pHother

Comparison of different dentifrice fluoride concentrations and pH on caries control