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Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

NCT ID: NCT01568541

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Subjects: Children at age of development of dental fluorosis (up to 4 years) enrolled at day care centres from the city of Montes Claros (0.7 ppm F), Brazil.

The study design has two phases:

1. In the first phase, children are required to bring at the day care centres the tooth brush and the toothpaste used at home. There is no randomization, since the inclusion in either children's or regular toothpaste groups will be done based on each child's preference. The children are requested to tooth brush as the usual manner that the parent and the child do at home. Saliva expectorates are collected as the protocol described by Guha-Chowdhury et al. (1996). No instructions are provided in this phase or interventions by the researcher. Saliva expectorates are collected for further laboratory analysis. Toothpastes are collected for laboratory analysis.
2. In the second phase, children are required to toothbrush with other type of toothbrush following the same tooth brushing protocol. For example, children that previously used children's toothpaste will be provided a regular toothpaste, and vice-versa.

Parents are requested to answer a questionnaire regarding their children's tooth brushing habits and socioeconomic factors.

Laboratory analysis provides estimation of fluoride intake from tooth brushing with both toothpastes.

Analysis will base on dose of fluoride intake (mg F/Kg body weight/day) considering children's and regular toothpastes.

Conditions

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Healthy Individuals

Keywords

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children dentifrice fluoride dental fluorosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Children' toothpaste

Children's toothpastes

Group Type ACTIVE_COMPARATOR

Regular toothpastes

Intervention Type DRUG

One tooth brushing

Regular toothpastes

Regular toothpastes

Group Type ACTIVE_COMPARATOR

Children's toothpastes

Intervention Type DRUG

One tooth brushing

Interventions

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Regular toothpastes

One tooth brushing

Intervention Type DRUG

Children's toothpastes

One tooth brushing

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role collaborator

State University of Montes Claros

UNKNOWN

Sponsor Role collaborator

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Carolina Castro Martins

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina C Martins, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

State University of Montes Claros

Montes Claros, Minas Gerais, Brazil

Site Status

Piracicaba School of Dentistry of State University of Campinas

Piracicaba, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 18319589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21776221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17823508 (View on PubMed)

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.

Reference Type RESULT
PMID: 21180793 (View on PubMed)

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.

Reference Type RESULT
PMID: 22163207 (View on PubMed)

Other Identifiers

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NCT17591320

Identifier Type: -

Identifier Source: org_study_id