NCT01623362

Evaluation of a Low Fluoride Dentifrice for Caries Control

Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Dental Caries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-07-01
• Completion: 2012-02-01
• First posted: 2012-06-20
• Last updated: 2012-06-20

Locations

1 site across 1 country: Brazil