Evaluation of a Low Fluoride Dentifrice for Caries Control

Phase 3

Completed

• Conditions: Dental Caries
• Interventions: Other: Low-fluoride acidic dentifrice; Other: conventional dentifrice; Other: neutral pH and low-fluoride dentifrice

• Registration Number: NCT01623362
• Lead Sponsor: Federal University of Paraíba

Brief 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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2012-05
• Study First Submitted: 2012-05-18
• Study First Submitted QC: 2012-06-15
• Last Update Submitted: 2012-06-15
• Study First Posted: 2012-06-20
• Last Update Posted: 2012-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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.

Exclusion Criteria

• Using orthodontic appliances

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-fluoride acidic dentifrice	Low-fluoride acidic dentifrice	-
Conventional dentifrice	conventional dentifrice	1100µgF/g-pH7.0
neutral pH and low-fluoride dentifrice	neutral pH and low-fluoride dentifrice	550 ppm pH 7

Primary Outcome Measures

Name	Time	Method
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities	6 months	Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)

Secondary Outcome Measures

Name	Time	Method
New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities	12 months	The caries progression/regression of active noncavited and progression of inactive noncavitated was evaluated by the date from the examinations at baseline and after 12 months using Nyvad, Machiulskienec, Baelum,1999: Score 0: Sound/ Score 1: Active caries (intact surface)/Score 2: Active caries (surface discontinuity)/Score 3: Active caries (cavity)/Score 4: Inactive caries(intact surface) /Score 5: Inactive caries (surface discontinuity) /Score 6: Inactive caries(cavity)/Score 7: Filling (sound surface)/Score 8: Filling + active caries/Score 9: Filling + inactive caries

Trial Locations

Locations (1)

Paraíba Federal University; 🇧🇷 João Pessoa, Paraíba, Brazil