Fluoride Intake From Toothbrushig With Children's or Regular Toothpastes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Individuals

Intervention / Treatment
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* Drug: Regular toothpastes
* Drug: Children's toothpastes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age up to 48 months. Compliance understands of the study and ability to comply with the study procedures. Good oral health as considered by the investigator. Good general health as considered by the investigator, with no clinically significant and/or relevant abnormalities of medical history. Exclusion Criteria: Children aging older than 48 months or younger of 6 months. Parents who do not allow the child's participation. Children that refuse to follow the study procedure. Volunteers that do not complete the whole study protocol.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Children' toothpaste<br>Children's toothpastes | Drug: Regular toothpastes<br>* One tooth brushing<br>|
| Active Comparator: Regular toothpastes<br>Regular toothpastes | Drug: Children's toothpastes<br>* One tooth brushing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes. |  | One week interval between two tooth brushings | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, fluoride, dentifrice, dental fluorosis