| CTRI Number |
CTRI/2025/04/084931 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Game based oral health education method on oral health of school going children |
|
Scientific Title of Study
|
Evaluating the impact of Game-based oral health education on 12 year old school children : A Randomized Field Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sajankumar Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital |
| Address |
Floor 6
Department of Public Health Dentistry
Government Dental College and Hospital
Civil Hospital Campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9638200103 |
| Fax |
|
| Email |
sajanpandya8591@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajankumar Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital |
| Address |
Floor 6
Department of Public Health Dentistry
Government Dental College and Hospital
Civil Hospital Campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9638200103 |
| Fax |
|
| Email |
sajanpandya8591@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajankumar Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College and Hospital |
| Address |
Floor 6
Department of Public Health Dentistry
Government Dental College and Hospital
Civil Hospital Campus
Asarwa
Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9638200103 |
| Fax |
|
| Email |
sajanpandya8591@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Sajankumar Pandya |
| Address |
Floor 6
Department of Public Health Dentistry
Government Dental College and Hospital
Civil Hospital Campus
Asarwa
Ahmedabad |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Janki Shah |
Floor 6
Dept of Public Health Dentistry
Government Dental College and Hospital
Asarwa
Ahmedabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sajankumar Pandya |
Government Dental College and Hospital Ahmedabad |
6th Floor
Department of Public Health Dentistry
Ahmadabad
GUJARAT |
9638200103
sajanpandya8591@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive and Screening intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Game based oral health education |
Interactive games
Maze
Snakes and Ladder
Connect the dots
Crosswords |
| Comparator Agent |
Traditional Oral Health Education Method |
Chalk and Talk
Audio Visual Method
Charts
|
|
|
Inclusion Criteria
|
| Age From |
11.12 Year(s) |
| Age To |
12.12 Year(s) |
| Gender |
Both |
| Details |
1 Studying in schools located within a 5-kilometre radius of Government Dental College and Hospital of Ahmedabad
2 School children assent and their gurdian consent
3 Present on the day of examination
|
|
| ExclusionCriteria |
| Details |
1 student absent on the day of the examination
2 Physically and mentally compromised students
3 students with restricted mouth opening |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Game based method of oral health education will have higher impact on oral hygiene status, behavior of 12 year old school going children |
At 3 intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Retention of oral health knowledge will be evaluated for game based oral health education method |
At 3 intervals |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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="0"
Months="1"
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 can cause discomfort and pain, which can cause distraction to children in playing and learning. Studies conducted across India from 2000 to 2021 showed a higher prevalence of dental caries and gingival diseases among 12 years old school going children. Traditional ways of teaching oral health education have shown an impact on the oral health status of school children, but newer ways of teaching can create difference too. Hence randomized field trial has been planned among 12-year-old school-going children in Ahmedabad city to evaluate and compare the impact of game based oral health education method with traditional method of teaching on oral hygiene status, behaviour and practices. |