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CTRI Number  CTRI/2025/04/085661 [Registered on: 25/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Dentistry
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Brighter Smiles at School: How Teaching Oral Health in Class Improves Kids Habits and Dental Health in Ranchi 
Scientific Title of Study   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  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit Vasant Mahuli 
Designation  Associate Professor  
Affiliation  Dental Institute, RIMS, Ranchi 
Address  Dept of Public Health Dentistry, Room No 7, Dental Institute, RIMS

Ranchi
JHARKHAND
834009
India 
Phone  8107960145  
Fax    
Email  amitmahuli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Amit Vasant Mahuli 
Designation  Associate Professor  
Affiliation  Dental Institute, RIMS, Ranchi 
Address  Dept of Public Health Dentistry, Room No 7, Dental Institute, RIMS


JHARKHAND
834009
India 
Phone  8107960145  
Fax    
Email  amitmahuli@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amit Vasant Mahuli 
Designation  Associate Professor  
Affiliation  Dental Institute, RIMS, Ranchi 
Address  Dept of Public Health Dentistry, Room No 7, Dental Institute, RIMS


JHARKHAND
834009
India 
Phone  8107960145  
Fax    
Email  amitmahuli@gmail.com  
 
Source of Monetary or Material Support  
Intra Mural Project approved by Rajendra Institute of Medical Science, Bariatu, Ranchi-834009, Jharkhand, India 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Science 
Address  Rajendra Institute of Medical Science, Bariatu, Ranchi-834009, Jharkhand, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Vasant Mahuli  Rajendra Institute of Medical Sciences   Department of Public Health Dentistry, Room no 7, Dental Institute, RIMS, Ranchi-834009, Jarkhand, India
Ranchi
JHARKHAND 
8107960145

amitmahuli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Ten- to fifteen year old schoolchildren with oral health issues  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Health education  Knowledge about oral diseases and their prevention. For one year period 
Intervention  Health education, curriculum changes, regular monitoring   Teachers training program (PE teachers), IEC materials for student education, Monthly lecture (30 min), Guided brushing technique demonstration, Self-monitoring of oral health, Knowledge about oral diseases and their prevention. For one year period 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  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  
 
ExclusionCriteria 
Details  Children with mental or physical disabilities or lacking fine motor skills. children suffering from chronic illness and under orthodontic treatment  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  Evaluation at 3,6,9 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="820"
Sample Size from India="820" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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