Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries in Non-fluoridated Areas: A 24-month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 主要终点
- Dental Caries
研究概览
简要总结
Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries Incident Cases, increment dmft index
详细描述
Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of Chile were invited to participate. Oral health education component was given to children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. The experimental group was treated with fluoride varnish every six months while the control group received placebo applications. A trained, calibrated dentists blinded to treatment arm performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. The number of incidents children with caries were recollected as the number of caries during the follow-up visits.
Nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in non-fluoridated areas.
Main outcome: Number of Caries Incident Cases, increment dmft index
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community.
排除标准
- •Children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.
研究组 & 干预措施
Fluoride varnish plus education
Biannual fluoride varnish every 6 month/ 24 months plus educational component
干预措施: Fluoride varnish plus education (Other)
Placebo varnish plus education
Biannual placebo varnish every 6 month/ 24 months plus educational component
干预措施: Fluoride varnish plus education (Other)
结局指标
主要结局
Dental Caries
时间窗: 24 months
Number of caries and incident cases
次要结局
- Caries increment(24 months)
研究者
Patricia Muñoz Millán
Staff
Universidad de La Frontera