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
CAPES (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

March 28, 2012
September 14, 2012
October 2007
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01568541 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Healthy Individuals
  • Drug: Regular toothpastes
    One tooth brushing
  • Drug: Children's toothpastes
    One tooth brushing
  • Active Comparator: Children' toothpaste
    Children's toothpastes
    Intervention: Drug: Regular toothpastes
  • Active Comparator: Regular toothpastes
    Regular toothpastes
    Intervention: Drug: Children's toothpastes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
March 2009
July 2008   (final data collection date for primary outcome measure)

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.
Both
6 Months to 48 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01568541
NCT17591320
Yes
Carolina Castro Martins, Federal University of Minas Gerais
Federal University of Minas Gerais
  • University of Campinas, Brazil
  • State University of Montes Claros
  • CAPES (Coordination for the Improvement of Higher Education Personnel)
  • FAPEMIG (State of Minas Gerais Research Foundation)
Principal Investigator: Carolina C Martins, PhD Federal University of Minas Gerais
Federal University of Minas Gerais
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP