Evaluation of a Low Fluoride Dentifrice for Caries Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low-fluoride acidic dentifrice

Group Type EXPERIMENTAL

Low-fluoride acidic dentifrice

Intervention Type OTHER

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

Conventional dentifrice

1100µgF/g-pH7.0

Group Type NO_INTERVENTION

conventional dentifrice

Intervention Type OTHER

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

neutral pH and low-fluoride dentifrice

550 ppm pH 7

Group Type EXPERIMENTAL

neutral pH and low-fluoride dentifrice

Intervention Type OTHER

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

Interventions

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Low-fluoride acidic dentifrice

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

Intervention Type OTHER

conventional dentifrice

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

Intervention Type OTHER

neutral pH and low-fluoride dentifrice

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

Intervention Type OTHER

Other Intervention Names

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G1 G2 G3

Eligibility Criteria

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Inclusion Criteria

* Age 2 to 4 years;
* Not having participated in any other clinical study within 3 months prior to selection;
* Not having very large carious lesions or dentin sensitivity during the study;
* Signature of informed consent by the parents.