| CTRI Number |
CTRI/2025/12/098798 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Gamifying oral health education using jigsaw puzzles and flash cards to improve knowledge, attitude, and practices among school children |
|
Scientific Title of Study
|
Gamifying oral health education by using jigsaw puzzle and flash cards to improve knowledge attitude and practice in school children |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPrerna Mishra |
| Designation |
Pediatric dentistry resident |
| Affiliation |
Peoples College of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9579912790 |
| Fax |
|
| Email |
drprernamishra01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShikha Mali |
| Designation |
Professor |
| Affiliation |
Peoples College of Dental Sciences |
| Address |
Deparatment of pediatric and preventive dentistry,Peoples college of dental sciences and research centre,bhanpur ,bhopal
Deparatment of pediatric and preventive dentistry,Peoples college of dental sciences and research centre,bhanpur ,bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8120388393 |
| Fax |
|
| Email |
shikha9290@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrerna Mishra |
| Designation |
Pediatric dentistry resident |
| Affiliation |
Peoples College of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9579912790 |
| Fax |
|
| Email |
drprernamishra01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India |
|
|
Primary Sponsor
|
| Name |
Peoples College of Dental Sciences and Research Centre Bhopal India |
| Address |
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhanpur, Bhopal, Madhya Pradesh – 462037, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Archna iyyer |
Podar international school |
Podar international school ayodhya bypass road
Bhopal
MADHYA PRADESH |
7999467704
iyerarchna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, People’s College of Dental Sciences and Research Centre, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health awareness and behavior improvement in school children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention 1 (Test Group A) |
Jigsaw Puzzle–Based Oral Health Education
Frequency: Once daily
Total Duration: 21 days
Mode: Supervised small-group educational session using the jigsaw puzzle tool |
| Intervention |
Intervention 2 (Test Group B) |
Flash Cards–Based Oral Health Education
Frequency: Once daily
Total Duration: 21 days
Mode: Supervised small-group session using oral health flash cards |
| Comparator Agent |
Traditional Oral Health Education |
Traditional Oral Health Education
Frequency: Once daily
Total Duration: 21 days
Mode: Standard lecture and demonstration on oral hygiene practices |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
School children aged 8–12 years in mixed dentition stage
Children attending participating schools
Consent obtained from parents/guardians |
|
| ExclusionCriteria |
| Details |
Children with systemic diseases or developmental disorders
Children previously exposed to structured oral health education programs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in oral health knowledge, attitude, and practice (KAP) scores from baseline to post-intervention assessment. |
Baseline, 4 weeks, and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Oral Hygiene Index (OHI-S) scores |
Baseline, 4 weeks, & 8 weeks. |
| Change in Plaque Index (Silness & Löe) scores |
Baseline, 4 weeks, & 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
22/12/2025 |
| 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="6"
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)?
Response - YES
- What data in particular will be shared?
Response (Others) - De-identified individual participant data that underlie the results reported in publications arising from the trial (including text, tables, figures, and appendices).
Additional de-identified participant data such as questionnaire responses, oral hygiene scores, and plaque index scores may be shared upon reasonable request after publication.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) - Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report
- Who will be able to view these files?
Response (Others) - Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the Institutional Review Committee of People’s College of Dental Sciences and Research Centre, Bhopal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (drprernamishra01@gmail.com).
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of gamified oral health education using jigsaw puzzles and flash cards in improving oral health knowledge, attitude, and practices among school children. The mixed dentition period is a crucial stage for establishing lifelong oral hygiene habits. Traditional teaching methods may have limited engagement and retention. Incorporating interactive tools such as puzzles and flash cards is expected to enhance learning, motivation, and behavioral outcomes. The study will compare gamified education with conventional teaching to assess improvements in knowledge, attitude, practices, and oral hygiene parameters. |