| CTRI Number |
CTRI/2025/07/091613 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of game-based learning on oral health education among school children |
|
Scientific Title of Study
|
Impact of game-based learning on oral health education among school children: 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 |
Sri Sai Srinivas Patta |
| Designation |
MDS |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9490106987 |
| Fax |
|
| Email |
ssssonu1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Vamsi Krishna Reddy |
| Designation |
Professor and Head of Department |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute of Dental Sciences, sanghivalasa, Visakhapatnam, AndhraPradesh-531162 |
|
|
Primary Sponsor
|
| Name |
Anil Neerukonda Institute of Dental Sciences sanghivalasa Visakhapatnam AndhraPradesh |
| Address |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh-531162 |
| Type of Sponsor |
Private 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 Sri Sai Srinivas Patta |
Anil Neerukonda Institute of Dental Sciences |
Anil Neerukonda Institute of Dental Sciences, Sanghivalasa, Bheemunipatnam, Visakhapatnam, AndhraPradesh-531162
Visakhapatnam
ANDHRA PRADESH |
9490106987
ssssonu1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee- ANIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children with no oral health awareness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
children before oral health education |
children before participating in game-based oral health education |
| Intervention |
game-based oral health education |
children after getting game based oral health education as intervention for 10 mins |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
healthy children who are willing to play game, which is based on oral health education |
|
| ExclusionCriteria |
| Details |
children with any mental illness
children who visited dentists previously |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of oral health education by using pre-tested and validated questionnaire |
before and after the intervention with a time period of 30minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| 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 Yet Recruiting |
| 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)?
|
|
Brief Summary
|
|
Introduction: The present study, the first of its kind, was
done to compare the efficacy of conventional and game based (matching cards) learning
on oral health status among 6 to 8-year-old children Aim: The Aim of this study was to assess the
effectiveness of game based oral health educational intervention
Objectives: To compare the efficacy of game based oral health educational intervention among school children by using self admisnistered questionnaire before and after intervention
|
|