Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

This study has been completed.
Sponsor:
Collaborators:
University of Campinas, Brazil
State University of Montes Claros
Coordination for the Improvement of Higher Education Personnel
FAPEMIG (State of Minas Gerais Research Foundation)
Information provided by (Responsible Party):
Carolina Castro Martins, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT01568541
First received: March 28, 2012
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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 Intervention
Healthy Individuals
Drug: Regular toothpastes
Drug: Children's toothpastes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children

Resource links provided by NLM:


Further study details as provided by Federal University of Minas Gerais:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fluoride concentrations in toothpastes used by children. [ Time Frame: From date of toothpastes collection until laboratorial analysis, assessed up to 4 months ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01568541

Locations
Brazil
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
FAPEMIG (State of Minas Gerais Research Foundation)
Investigators
Principal Investigator: Carolina C Martins, PhD Federal University of Minas Gerais
  More Information

Additional Information:
Publications:
Responsible Party: Carolina Castro Martins, Principal Investigator, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT01568541     History of Changes
Other Study ID Numbers: NCT17591320
Study First Received: March 28, 2012
Last Updated: September 14, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Minas Gerais:
children
dentifrice
fluoride
dental fluorosis

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

ClinicalTrials.gov processed this record on September 18, 2014