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Completed

NCT Number: NCT01568541

Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

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.

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Key information

Conditions

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

Age range

6 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Regular toothpastes

Drug

One tooth brushing

Children's toothpastes

Drug

One tooth brushing

Primary outcomes

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

    Time frame: One week interval between two tooth brushings

Secondary outcomes

  1. Fluoride concentrations in toothpastes used by children.

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

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • 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

Registry information

Official study title

Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children

Acronym: F

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Apr 2, 2012
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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