Study on Children's Dental Caries Prevention and Mechanism
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The number of new cavitated or incipient carious lesion
研究概览
简要总结
Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children
详细描述
Different caries prevention trials including fluoride vanish, IgY-passive immunotherapy and probiotics lasting 24 months were conducted with a total of 500 children aged 24 to 54 months of age in Lin'an, Zhejiang, China. The trials were cluster- domized .After obtaining parent´s informed consent, preschool children were clinical examinated according to ICDAS-Ⅱ and microbiological tested of saliva at baseline, 1m, 6m, 12m, 18m and 24m. To find the differences of caries incidence and oral microecology change in four groups, dmfs will be assessed and saliva will be analysed in experiment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preschool children in good general health
- •At least 18 deciduous teeth
排除标准
- •With major systemic disease or on long-term medication
- •Not cooperative and refuse dental treatment
- •With a history of extra fluoride supplement
- •Take antibiotics for nearly 8 weeks
研究组 & 干预措施
fluoride varnish
fluoride varnish every 6 months
干预措施: fluoride varnish (Drug)
ImmunoglobulinY
anti-S.mutans Immunoglobulin yolk for everyday use
干预措施: Immunoglobulin Yolk (Biological)
Probiotics
Probiotics use for 1 months
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
The number of new cavitated or incipient carious lesion
时间窗: 24 months after first visit
To determine whether preschool children that only with caregiver behavior education have more new caries lesion than those taken some caries preventive measures by differences in dmfs（decay，missing，filling teeth surfaces） index after 24 months dental exams.
次要结局
未报告次要终点
研究者
Xi Chen
Master
Zhejiang University