Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

NCT01568541 | Completed DMC

• 1 other identifier: NCT17591320
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy Individuals

Keywords

children; dentifrice; fluoride; dental fluorosis

Outcome Measures

Primary Outcomes (1)

• Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes.

  One week interval between two tooth brushings

Secondary Outcomes (1)

• Fluoride concentrations in toothpastes used by children.

  From date of toothpastes collection until laboratorial analysis, assessed up to 4 months

Study Arms (2)

Children' toothpaste

ACTIVE COMPARATOR

Children's toothpastes

Drug: Regular toothpastes

Regular toothpastes

ACTIVE COMPARATOR

Regular toothpastes

Drug: Children's toothpastes

Interventions

Regular toothpastes DRUG

One tooth brushing

Children' toothpaste

Children's toothpastes DRUG

One tooth brushing

Regular toothpastes

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Age up to 48 months.
• Compliance understands of the study and ability to comply with the study procedures.
• Good oral health as considered by the investigator.
• Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history.

You may not qualify if:

• Children aging older than 48 months or younger of 6 months.
• Parents who do not allow the child's participation.
• Children that refuse to follow the study procedure.
• Volunteers that do not complete the whole study protocol.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• University of Campinas, Brazil: collaborator
• State University of Montes Claros: collaborator
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (3)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

State University of Montes Claros

Montes Claros, Minas Gerais, 39401-089, Brazil

Location

Piracicaba School of Dentistry of State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (5)

• 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.

  PMID: 18319589 BACKGROUND

• 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.

  PMID: 21776221 BACKGROUND

• 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. doi: 10.1159/000107933. Epub 2007 Sep 7.

  PMID: 17823508 BACKGROUND

• 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. doi: 10.1590/s0103-64402010000500003.

  PMID: 21180793 RESULT

• 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 Nov 10.

  PMID: 22163207 RESULT

MeSH Terms

Conditions

Fluorosis, Dental

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carolina C Martins, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 2, 2012
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: March 1, 2009
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

BR (3)