Fluoride Intake From Tooth Brushing With Children's and Regular Toothpastes: a Study With Preschooler Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 3
- 主要终点
- Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Children' toothpaste
Children's toothpastes
干预措施: Regular toothpastes (Drug)
Regular toothpastes
Regular toothpastes
干预措施: Children's toothpastes (Drug)
结局指标
主要结局
Evidence of mean dose of fluoride intake from tooth brushing with children's and regular toothpastes.
时间窗: One week interval between two tooth brushings
次要结局
- Fluoride concentrations in toothpastes used by children.(From date of toothpastes collection until laboratorial analysis, assessed up to 4 months)
研究者
Carolina Castro Martins
Principal Investigator
Federal University of Minas Gerais