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

September 14, 2012 updated by: Carolina Castro Martins, Federal University of Minas Gerais

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One week interval between two tooth brushings

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

University of Campinas, Brazil
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Coordination for the Improvement of Higher Education Personnel
State University of Montes Claros

Investigators

  • Principal Investigator: Carolina C Martins, PhD, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 14, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCT17591320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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