CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Toothpastedrug
Likely dose
Toothpaste 0.3 gfrom 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/NCT01589991
NCT01589991Phase 1Completed
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Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

University of Campinas, Brazil·interventional·Posted May 2, 2012·Updated Oct 28, 2013

In Brief

A Phase 1 clinical trial evaluating Toothpaste for Dental Caries and Dental Fluorosis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries, Dental Fluorosis
CountriesBrazil
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2, 2012
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.2 years ago

Interventions

Toothpastedrug

The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.