Clinical Analysis of Cariogram and Cariostat for Risk Assessment and Comprehensive Intervention of Early-childhood-caries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.
研究概览
简要总结
Cariogram and Cariostat will be used to assess the risk of caries in kindergarten children aged 3 years. Routine preventive measures will be taken for children at low risk of caries, and intensive intervention measures will be taken for children at medium and high risk. Routine measures will be taken for the control group. After one and two year, the prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
详细描述
Caries risk-graded intervention for preschool children is needed as different child has different risk to suffer from caries.
Cariogram and Cariostat are two different and common caries risk assessment tools. Cariogram is a complicated but economical computer program which is more sensitive for caries risk assessment. Cariostat is a biological reagents with high specificity but it may be expensive to use for large numbers of children.
The experimental group will be divided into two subgroups, one use Cariogram and the other use Cariostat to assess the risk. Based on the results of the assessment, children with low risk of caries will get routine prevention including twice fluorinated foams each year and hygiene. Children with middle or high risk of caries will receive twice fluorinated varnish each year and professional caries treatment in addition to routine prevention.Routine prevention will be taken for the control group with both Cariogram and Cariostat assessment.
Follow-up will arrange one and two years after baseline recruitment. All participants will receive oral health-related questionnaires at baseline and follow-up.
The prevalence of caries in the experimental group and the control group should be evaluated, and the cost-effectiveness evaluation will be conducted.
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
- Single (Outcomes Assessor)
盲法说明
After the data is entered, the analyst is analyzed under the premise of uninformed, and the packet is performed after all analyzes are completed.
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Junior kindergarten children who enter the kindergarten in September 2021 and can cooperate with the oral health examination.
- •Parents of children fully understand the purpose of the study, cooperate with the questionnaire survey during the study, give informed consent and sign the informed consent form.
- •The child has no serious systemic diseases, has not taken hormones and immunosuppressants within 6 months, and has no history of antibiotic use within 1 month，and is not allergic to fluoride.
排除标准
- •Parents of children refuse to provide information about children's oral health or questionnaires.
- •Children cannot cooperate with oral health examination.
- •The child has a serious systemic disease that may affect the results of the study.
- •Children who are allergic to fluoride.
结局指标
主要结局
Decay teeth,Missed teeth and filled teeth (DMFT) and the change between different time points.
时间窗: Baseline, one year follow up and two year follow up.
The average value of the sum of the number of decayed teeth, the number of filled teeth, and the number of missed teeth due to caries.
次要结局
- Caries prevalence and the change between different time points.(Baseline, one year follow up and two year follow up.)