| 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
|
|
|
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
|
|
|
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. |