Clinical Trial: Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Campinas, Brazil

Current Primary Outcome:

• 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.
• 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).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• Amount of toothpaste ingested [ Time Frame: January 2013 to July 2013 ]
  Determination of amount of toothpaste ingested after one simulated brushing.

Original Secondary Outcome:

• 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.
• 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.

Information By: University of Campinas, Brazil

Dates:
Date Received: April 30, 2012
Date Started: January 2011
Date Completion:
Last Updated: October 25, 2013
Last Verified: October 2013