Healthy Individuals Clinical Trial
— FOfficial title:
Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children
There are controversial data about fluoride intake by children when tooth brushing with children's or regular toothpastes. However, a study have showed that children were exposed to a dose of 0.051 mg F/Kg/day and 0.046 mg F/kg/day by tooth brushing with children's and and regular toothpaste, respectively. Fluorides doses were too close and is questioned if there is a real clinical relevance in terms of risk of dental fluorosis. It is important to evaluate if children's toothpastes does really represent a risk of fluoride intake when compared to the regular toothpastes in terms of risk of dental fluorosis. The hypothesis is that both children's and regular toothpastes can represente risks of development of dental fluorosis and can represent similar fluoride exposure by children.
Status | Completed |
Enrollment | 208 |
Est. completion date | March 2009 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 48 Months |
Eligibility |
Inclusion Criteria: 1. Consent demonstrates understanding of the study and willingness to participate as evidenced by voluntary written of informed consent and has received a signed and dated copy of the informed consent form. 2. Age up to 48 months. 3. Compliance understands of the study and ability to comply with the study procedures. 4. Good oral health as considered by the investigator. 5. Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history. Exclusion Criteria: 1. Children aging older than 48 months or younger of 6 months. 2. Parents who do not allow the child's participation. 3. Children that refuse to follow the study procedure. 4. Volunteers that do not complete the whole study protocol. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais |
Brazil | State University of Montes Claros | Montes Claros | Minas Gerais |
Brazil | Piracicaba School of Dentistry of State University of Campinas | Piracicaba | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais | Coordination for the Improvement of Higher Education Personnel, Fundação de Amparo à Pesquisa do estado de Minas Gerais, State University of Montes Claros, University of Campinas, Brazil |
Brazil,
Cury JA, Oliveira MJ, Martins CC, Tenuta LM, Paiva SM. Available fluoride in toothpastes used by Brazilian children. Braz Dent J. 2010;21(5):396-400. — View Citation
Martins CC, Oliveira MJ, Pordeus IA, Cury JA, Paiva SM. Association between socioeconomic factors and the choice of dentifrice and fluoride intake by children. Int J Environ Res Public Health. 2011 Nov;8(11):4284-99. doi: 10.3390/ijerph8114284. Epub 2011 — View Citation
Martins CC, Paiva SM, Cury JA. Effect of discontinuation of fluoride intake from water and toothpaste on urinary excretion in young children. Int J Environ Res Public Health. 2011 Jun;8(6):2132-41. doi: 10.3390/ijerph8062132. Epub 2011 Jun 10. — View Citation
Martins CC, Paiva SM, Lima-Arsati YB, Ramos-Jorge ML, Cury JA. Prospective study of the association between fluoride intake and dental fluorosis in permanent teeth. Caries Res. 2008;42(2):125-33. doi: 10.1159/000119520. Epub 2008 Mar 4. — View Citation
Oliveira MJ, Paiva SM, Martins LH, Ramos-Jorge ML, Lima YB, Cury JA. Fluoride intake by children at risk for the development of dental fluorosis: comparison of regular dentifrices and flavoured dentifrices for children. Caries Res. 2007;41(6):460-6. Epub 2007 Sep 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes. | One week interval between two tooth brushings | Yes | |
Secondary | Fluoride concentrations in toothpastes used by children. | From date of toothpastes collection until laboratorial analysis, assessed up to 4 months | No |
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