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CompletedNCT01568541FUpdated Sep 18, 2012

Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

An interventional study of Regular toothpastes and Children's toothpastes in Healthy Individuals, sponsored by Federal University of Minas Gerais. Completed at 3 sites in Brazil. Open to participants aged 6 Months to 48 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Non-randomized
Ages
6 Months to 48 Months
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Healthy Individuals

Keywords

  • children
  • dentifrice
  • fluoride
  • dental fluorosis
03

In context

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 48 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
208 participants (actual)

Study arms

  • Active comparator
    Children' toothpaste

    Children's toothpastes

    Drug: Regular toothpastes

  • Active comparator
    Regular toothpastes

    Regular toothpastes

    Drug: Children's toothpastes

Interventions

  • DrugRegular toothpastes

    One tooth brushing

  • DrugChildren's toothpastes

    One tooth brushing

06

What researchers measure

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

07

Study locations

3 sites
  • Universidade Federal de Minas Gerais
    Belo Horizonte, Minas Gerais 31270-901, Brazil
  • State University of Montes Claros
    Montes Claros, Minas Gerais 39401-089, Brazil
  • Piracicaba School of Dentistry of State University of Campinas
    Piracicaba, São Paulo 13414-903, Brazil
08

References and documents

Publications

  • 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. PubMed 18319589 ↗
  • 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. PubMed 21776221 ↗
  • 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. PubMed 17823508 ↗
  • 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. PubMed 21180793 ↗
  • 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. PubMed 22163207 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01568541
Lead sponsor
Federal University of Minas Gerais
Collaborators
University of Campinas, Brazil, State University of Montes Claros, Coordination for the Improvement of Higher Education Personnel, Fundação de Amparo à Pesquisa do estado de Minas Gerais
Responsible party
Carolina Castro Martins (Principal Investigator, Federal University of Minas Gerais) — Principal investigator
First posted
Apr 2, 2012
Start date
Oct 2007
Primary completion
Jul 2008
Completion
Mar 2009
Last update
Sep 18, 2012

Study contacts

Carolina C Martins, PhD
principal investigator · Federal University of Minas Gerais

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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