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Completed

NCT Number: NCT01589991

Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.

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Key information

Conditions

Dental Caries Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Dental Fluorosis Developmental Defects of Enamel Fluorosis, Dental Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Demineralization Tooth Diseases

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Piracicaba Dental School, University of Campinas

Piracicaba, São Paulo, 13414903, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Good general health
  • Good oral health

Treatment and study plan

Toothpaste

Drug

The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.

Primary outcomes

  1. Fluoride concentration in biofilm fluid

    Time frame: 30min

    Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm fluid will be determined by a fluoride electrode adapted for microanalysis.

  2. Urinary fluoride excretion

    Time frame: 8h

    Urine will be collected at two time-points, either before the use of the toothpaste or at the last day of use, in each experimental phase. Fluoride concentration was determined by an inverted ion-specific fluoride electrode and fluoride excretion will be measured by fluoride/cratinine ratio (mg F/mg creatinine).

Secondary outcomes

  1. Fluoride concentration in biofilm solid

    Time frame: 30min

    Remants of dental plaque (biofilm) will be collected 30 min after brushing with the toothpastes, the fluid will be separated from the solids by centrifugation and the fluoride concentration in the biofilm solids will be determined after acid extraction using a fluoride electrode adapted for microanalysis.

  2. Fluoride concentration in saliva

    Time frame: 30min

    Non-stimulated saliva will be collected at 0 (immediately before toothbrushing), 7, 15 and 30 min after toothbrushing. Fluoride concentration in saliva will be determined by a ion-specific fluoride electrode, adapted for microanalysis.

  3. Amount of toothpaste ingested

    Time frame: January 2013 to July 2013

    Determination of amount of toothpaste ingested after one simulated brushing.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 2, 2012
Registry last updated
Oct 28, 2013

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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