Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

University of Campinas, Brazil

Status and phase: Completed; Phase 1

Conditions: Dental Fluorosis; Dental Caries

Treatments: Drug: Toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT01589991

FOPBioq002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 3 to 4 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Good general health
• Good oral health

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 4 patient groups, including a placebo group

Non-fluoride toothpaste

Placebo Comparator group

Treatment:

Drug: Toothpaste

Toothpaste 550 µg F/g (NaF/SiO2)

Experimental group

Treatment:

Drug: Toothpaste

Toothpaste 1100 µg F/g (NaF/SiO2)

Experimental group

Treatment:

Drug: Toothpaste

Toothpaste 1450 µg F/g (MFP/CaCO3)

Experimental group

Treatment:

Drug: Toothpaste