Recruitment

Recruitment Status
Completed

Summary

Conditions
Healthy Individuals
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Crossover AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 648 years
Gender
Both males and females

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: In the first phase, children are required to bring at the day care centres the tooth brush and the toothpaste...

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: 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. 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.

Tracking Information

NCT #
NCT01568541
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
Investigators
Principal Investigator: Carolina C Martins, PhD Federal University of Minas Gerais