Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Phase 1

Completed

• Conditions: Dental Caries; Dental Fluorosis
• Interventions: Drug: Toothpaste

• Registration Number: NCT01589991
• Lead Sponsor: University of Campinas, Brazil

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 Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Good general health
• Good oral health

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-fluoride toothpaste	Toothpaste	-
Toothpaste 1100 µg F/g (NaF/SiO2)	Toothpaste	-
Toothpaste 550 µg F/g (NaF/SiO2)	Toothpaste	-
Toothpaste 1450 µg F/g (MFP/CaCO3)	Toothpaste	-

Primary Outcome Measures

Name	Time	Method
Fluoride concentration in biofilm fluid	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	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 Outcome Measures

Name	Time	Method
Fluoride concentration in biofilm solid	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	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	January 2013 to July 2013	Determination of amount of toothpaste ingested after one simulated brushing.

Trial Locations

Locations (1)

Piracicaba Dental School, University of Campinas; 🇧🇷 Piracicaba, Sao Paulo, Brazil