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Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes (F)

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ClinicalTrials.gov Identifier: NCT01568541
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Healthy Individuals Drug: Regular toothpastes Drug: Children's toothpastes

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children
Study Start Date : October 2007
Primary Completion Date : July 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Children' toothpaste
Children's toothpastes
Drug: Regular toothpastes
One tooth brushing
Active Comparator: Regular toothpastes
Regular toothpastes
Drug: Children's toothpastes
One tooth brushing

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Fluoride concentrations in toothpastes used by children. [ Time Frame: From date of toothpastes collection until laboratorial analysis, assessed up to 4 months ]

Eligibility Criteria

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Ages Eligible for Study:   6 Months to 48 Months   (Child)
Sexes Eligible for Study:   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:

  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568541

Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
State University of Montes Claros
Montes Claros, Minas Gerais, Brazil, 39401-089
Piracicaba School of Dentistry of State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
Federal University of Minas Gerais
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
Principal Investigator: Carolina C Martins, PhD Federal University of Minas Gerais
More Information

Additional Information:
Responsible Party: Carolina Castro Martins, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01568541     History of Changes
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: September 2012

Keywords provided by Carolina Castro Martins, Federal University of Minas Gerais:
dental fluorosis

Additional relevant MeSH terms:
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs