MedTrace Logo

Evaluation of a Low Fluoride Dentifrice for Caries Control

NCT01623362 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2012-06-20

No results posted yet for this study

Summary

The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.

Conditions

  • Dental Caries

Interventions

OTHER

Low-fluoride acidic dentifrice

550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.

OTHER

conventional dentifrice

1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months

OTHER

neutral pH and low-fluoride dentifrice

500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months

Sponsors & Collaborators

  • Federal University of Paraíba

    lead OTHER

Principal Investigators

  • Fábio Sampaio, PhD · Paraíba Federal University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-07-31
Completion
2012-02-29

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT01623362 on ClinicalTrials.gov