| CTRI Number |
CTRI/2025/07/090369 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of school dental health education on oral health status of tribal school children. |
|
Scientific Title of Study
|
Effectiveness of different modes of school dental health education on oral health status of tribal school children aged 6-12 years in Salem district – 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 |
MOTHIRAJATHI K |
| Designation |
PG student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
Namakkal
TAMIL NADU
637215
India |
| Phone |
07550144823 |
| Fax |
|
| Email |
mothikumaresh0812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha Priya PR |
| Designation |
Professor and Head of the Department |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843194402 |
| Fax |
|
| Email |
geethapriya@ksridsr.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MOTHIRAJATHI K |
| Designation |
PG Student |
| Affiliation |
KSR Institute of Dental Science and Research |
| Address |
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
No.5 Department of Pediatric and Preventive Dentistry, KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215
Namakkal
TAMIL NADU
637215
India |
| Phone |
07550144823 |
| Fax |
|
| Email |
mothikumaresh0812@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mothirajathi K |
| Address |
KSR Institute of Dental Science and Research, KSR Kalvi Nagar, Thokkavadi, Tiruchengode-637 215 |
| Type of Sponsor |
Other [self] |
|
|
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 Mothirajathi K |
KSR Institute of Dental Science and Research |
Department of Pediatric and Preventive Dentistry
KSR Institute of Dental Science and Research
KSR Kalvi Nagar
Thokkavadi
Tiruchengode637215
Namakkal
TAMIL NADU |
7550144823
mothikumaresh0812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSRIDSR Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flashcards |
- A set of colourful flashcards, each measuring 8 × 12 inches, will be developed as a visual aid to enhance oral health education among children. Featuring a range of relatable scenarios, the flashcards used age-appropriate illustrations and concise messages to convey key oral hygiene practices. |
| Intervention |
Modified snake and ladder game |
A customized Snake and Ladder game board, measuring 18 × 18 inches, will be developed as an interactive tool to promote oral health education. The board will feature vibrant, pictorial illustrations that depicts various oral health practices along with their consequences. This visually engaging format will be designed to reinforce key oral hygiene messages in a fun and memorable manner. Created specifically for children, the game skillfully will combine learning with play to encourage the development of healthy dental habits. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Tribal school children aged 6-12 years residing in Salem district.
2.Children of the parent who give consent for participating in the study.
|
|
| ExclusionCriteria |
| Details |
1.Children with high caries rate and severe crowding.
2.Children with any diagnosed systemic illness.
3.Children with special health care needs will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.deft/DMFT Index
2.Gingival Index
3.Simplified oral hygiene Index
4.Knowledge, attitude and practice questionnaire
5.Child oral health impact profile- short form(COHIP-SF) Questionnaire.
|
Baseline,3 and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Knowledge, attitude and practice(KAP) questionnaire
2.Child Oral Health Impact Profile- Short Form(COHIP- SF) Questionnaire.
|
Baseline,3 and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
21/07/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This randomized control trial evaluates the effectiveness of two School Dental Health Education (SDHE) methods—flashcards and a modified Snake and Ladder game—among tribal school children aged 6–12 years in Salem district, Tamil Nadu. - A sample of 350 children (175 per group) from four randomly selected boarding schools receive SDHE through either flashcards (control) or a game-based method (intervention), with assessments at baseline, 3 months, and 6 months.
- Objectives: To compare the effectiveness of game-based vs. traditional flashcard SDHE.
Key Assessments: - Oral health indices (deft/DMFT, Gingival Index, Simplified Oral Hygiene Index)
- Knowledge, Attitude, and Practice (KAP) questionnaire
- Child Oral Health Impact Profile – Short Form (COHIP-SF) for quality of life
Expected Outcomes: - Enhanced oral health status and knowledge in children receiving game-based SDHE.
Implications: The study provides evidence-based guidance for implementing culturally appropriate, engaging SDHE methods in tribal schools. It supports the integration of oral health education into school curricula to improve child health outcomes in underserved communities.
|