Development and validation of oral health curriculum for schools in Kerala: A cluster-randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Change in index scores (DMFT, OHI-S) and difference in knowledge, attitudes, and practices regarding oral hygiene
研究概览
简要总结
This is a cluster-randomized trial with the intervention arm receiving the developed oral health curriculum and the control arm continuing with the existing school health curriculum. The intervention arm is subdivided into two groups - group 1 where the curriculum will be administered by the dental professional and group 2 where the school teacher will administer the curriculum. The target population is children from grades 1-7 in CBSE, ICSE, and state syllabus schools in Ernakulam and Kollam districts in Kerala. Both English and Malayalam medium schools will be selected. Each school will be considered a cluster. The minimum cluster size is 20 students per school.
Selected schools are randomized using the lottery method. The total sample size is 6000. Data will be collected at baseline, after 1 year (mid-term), and after 2 years (final). The outcome measures are DMFT (Decayed Missing and Filled Teeth index), OHI-S (Oral Hygiene Index -simplified), and KAB (Knowledge, Attitude and Behaviour). Data collection will be carried out by clinical oral examination and KAB questionnaire.
The developed oral health curriculum will comprise oral hygiene instructions and demonstrations for oral health promotion which will be implemented to the schoolchildren for a period of two years. One session will be conducted every four months. The curriculum will be divided into modules with age-appropriate instructions for students. Lesson plans with instructions, hands-on demonstrations, handouts, or master copy will also be provided.
Change in index scores (DMFT, OHI-S) and difference in knowledge, attitude, and behaviour regarding oral hygiene post-intervention will be measured and a comparison of scores between intervention and control groups will be done. We will also compare and calculate the scores of the intervention group between participants taught by dentist and school teacher
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Students of standards 1 to 7 in schools at Ernakulam and Kollam districts of Kerala ii.
- •Students who are willing to participate in the study and whose parents/ guardians have given the consent.
排除标准
- •Students who are not willing to participate in the study.
- •Students whose parents/ guardians do not give consent for participating in the study.
结局指标
主要结局
Change in index scores (DMFT, OHI-S) and difference in knowledge, attitudes, and practices regarding oral hygiene
时间窗: - Baseline | - After 1 year | - After 2 years
post-intervention
时间窗: - Baseline | - After 1 year | - After 2 years
次要结局
- Index and KAB Score comparison(2)