A Phase 1 interventional study of Toothpaste in Dental Caries and Dental Fluorosis, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to participants aged 3 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-28.
Sponsored by University of Campinas, Brazil · Phase 1, Interventional, and Prevention
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: Toothpaste
Drug: Toothpaste
Drug: Toothpaste
Drug: Toothpaste
The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
Fluoride concentration in biofilm fluid
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.
Time frame: 30min
Urinary fluoride excretion
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).
Time frame: 8h
Fluoride concentration in biofilm solid
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.
Time frame: 30min
Fluoride concentration in saliva
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.
Time frame: 30min
Amount of toothpaste ingested
Determination of amount of toothpaste ingested after one simulated brushing.
Time frame: January 2013 to July 2013
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil