Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes
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 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|
- 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 ]
- 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 ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Children' toothpaste
Drug: Regular toothpastes
One tooth brushing
Active Comparator: Regular toothpastes
Drug: Children's toothpastes
One tooth brushing
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Carolina C Martins, PhD||Federal University of Minas Gerais|