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临床试验/CTRI/2025/04/085661
CTRI/2025/04/085661尚未招募不适用

Effect of school oral health education through curriculum changes on behaviour and oral health status of children aged 10-15 years in Ranchi city: A Randomized Control Trial

Rajendra Institute of Medical Science1 个研究点 分布在 1 个国家目标入组 820 人开始时间: 2025年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
820
试验地点
1
主要终点
To assess the effect of school health education, with or without curriculum changes, on the behaviour and oral health status of children aged 10–15 years using WHO Oral Health Assessment Form for Children, 2013 and Behaviour will be checked using Oral Health Questionnaire for children, WHO

研究概览

简要总结

Oral diseases are largely preventable and linked to poor oral hygiene practices that begin during childhood. Schools are important platforms for promoting healthy behaviour and preventing oral health problems. The school oral health education programme has been found to be effective in preventing oral diseases and instilling lifelong positive behavioural changes among adolescents. However, the current school curriculum in India lacks a structured approach towards oral health education and disease prevention. According to the National Oral Health Survey 2002–2003, the maximum prevalence of oral diseases is observed among children aged 10 to 15 years. The survey also revealed that over 40 percent of 12-year-old children across rural and urban areas had no knowledge of oral health problems. The draft National Oral Health Policy advocates for an intersectoral approach that includes schools, aiming for a 15 percent reduction in the burden of oral diseases by 2030. This study seeks to generate evidence on the effectiveness of integrating oral health education into the school curriculum in a structured format.

The primary aim of the study is to assess and compare the effect of school oral health education, with or without changes to the school curriculum, on the behaviour and oral health status of children aged 10 to 15 years. A parallel design cluster randomized controlled trial will be conducted over a period of two years in government schools of Ranchi city. The study population includes male and female students from grades 5 to 9. Schools will be selected using cluster random sampling, and each school will represent one cluster. A total of 10 clusters will be selected and randomized into two groups: the intervention group and the control group, with five schools in each group. The control group will receive oral health education by a team of dentists during visits at baseline, third, sixth, ninth, and twelfth months. The intervention group will receive the same oral health education plus curriculum modifications delivered by trained physical education teachers. These modifications include monthly lectures of 30 minutes, provision of IEC materials, guided brushing technique demonstrations, self-monitoring practices, and knowledge about oral diseases and their prevention. All participants will be provided with toothbrushes and toothpaste during the study period to ensure standardized oral hygiene practices.

The oral health status of the students will be evaluated using the WHO Oral Health Assessment Form for Children 2013, and their behaviour will be assessed using the WHO Oral Health Questionnaire for Children. The sample size was estimated at 410 participants per group based on expected reduction in gingivitis prevalence by 33.33 percent with an ICC of 0.8 at 95 percent confidence and 80 percent power. Data analysis will include descriptive statistics, repeated measures ANOVA, and post hoc tests using R software. Ethical approval will be obtained from the RIMS Institutional Ethics Committee. Permissions will also be secured from the education department and participating schools. Parental consent will be obtained for all children. The study aims to provide evidence for effective school-based oral health education and support policy-level decisions for integration of oral health into the national and state education systems.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
10.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • •School children 10-15 years old from government schools of Ranchi consenting to participate in the study.
  • •Blanket approval from the school administration will be obtained.

排除标准

  • •Children with mental or physical disabilities or lacking fine motor skills.
  • •children suffering from chronic illness and under orthodontic treatment.

结局指标

主要结局

To assess the effect of school health education, with or without curriculum changes, on the behaviour and oral health status of children aged 10–15 years using WHO Oral Health Assessment Form for Children, 2013 and Behaviour will be checked using Oral Health Questionnaire for children, WHO

时间窗: Evaluation at 3,6,9 and 12 months

次要结局

  • To compare the effect of school health education, with or without curriculum changes, on the behaviour & oral health status of children(Evaluation at 3,6,9and 12 months time interval)

研究者

发起方
Rajendra Institute of Medical Science
申办方类型
Government medical college

研究点 (1)

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