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Completed

NCT Number: NCT01623362

Evaluation of a Low Fluoride Dentifrice for Caries Control

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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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paraíba Federal University

João Pessoa, Paraíba, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-fluoride acidic dentifrice

Other

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

Other names: G1

conventional dentifrice

Other

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

Other names: G2

neutral pH and low-fluoride dentifrice

Other

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

Other names: G3

Primary outcomes

  1. Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities

    Time frame: 6 months

    Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)

Secondary outcomes

  1. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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