| CTRI Number |
CTRI/2025/12/099602 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a New Health Education Program on Eating Habits, Saliva Acidity, and Oral Health Practices among Participants: A Randomized Controlled Study |
|
Scientific Title of Study
|
Effectiveness of A Novel MART -Multimodal Active, Reflective, and Transformative Health Intervention on Eating Attitudes, Salivary pH and Oral health Behaviours: A Randomized controlled trial |
| Trial Acronym |
MART |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthiga S |
| Designation |
Post graduate |
| Affiliation |
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
7845808792 |
| Fax |
|
| Email |
msakthikarthi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Karthiga S |
| Designation |
Post graduate |
| Affiliation |
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
KARNATAKA 590010 India |
| Phone |
7845808792 |
| Fax |
|
| Email |
msakthikarthi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopali M Sankeshwari |
| Designation |
Professor and HOD |
| Affiliation |
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9844837197 |
| Fax |
|
| Email |
docrups@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Association of Public Health Dentistry Financial Assistance to MDS Research Projects,
Head office: 32-401 , Milroc Kadamba , Old Goa , Goa - 403402 |
|
|
Primary Sponsor
|
| Name |
Dr Karthiga S |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHERs KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka |
| Type of Sponsor |
Other [Indian Association of Public Health Dentistry] |
|
|
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 |
| Principal |
Government Marathi School |
Room no.2, Kakti, Belagavi, Karnataka. Belgaum KARNATAKA |
9964832280
msakthikarthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children aged 9-12 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional health education |
Children will be given oral health education at 7th, 21st and 45th day about oral hygiene maintainence. |
| Intervention |
Multimodal Active, Reflective and Transformative Health Intervention |
Children will be given multimodal intervention at first week, reinforcement at 21st day, 45th day to improve their eating habits, knowledge about oral hygiene by cognitive methods like critical thinking and problem solving. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 9-12 years without any underlying health condition.
Children willing to participate and give assent form |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, Attitude, Plaque and Gingival index, Mini EAT assessment |
Baseline, 7th day, 21st day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| Date of Study Completion (India) |
14/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The multimodal educational programme proved to be a powerful tool for strengthening oral health knowledge, positive attitudes toward dental care and reported oral hygiene practices and for controlling dental plaque. A nutritionally adequate and balanced diet is essential for optimal child growth and development. During this phase, adolescents establish patterns of behaviour for instance, related to diet, physical activity, substance use, and sexual activity that can protect their health and the health of others around them, or put their health at risk now and in the future. The conditions of an oral health optimized diet seem to significantly reduce several species in dental plaque and saliva. |