| CTRI Number |
CTRI/2025/01/079239 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Screening
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Finding the Best Way to Teach Kids About Oral Hygiene |
|
Scientific Title of Study
|
A comparative Evaluation of Different School Oral Health Education Methods In Improving Children Oral Health status A Randomised 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 |
Sanjukta Panda |
| Designation |
PhD Scholar |
| Affiliation |
KALINGA INSTITUTE OF DENTAL SCIENCES, KIIT-DU |
| Address |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Campus - 5, Patia Bhubaneswar - 751024, Odisha
Khordha
ORISSA
751024
India |
| Phone |
09438166683 |
| Fax |
|
| Email |
sanjukta.panda@kids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. ABINASH MOHAPATRA |
| Designation |
PROFESSOR |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
| Address |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Campus - 5, Patia Bhubaneswar - 751024, Odisha
ORISSA
751024
India |
| Phone |
9437214000 |
| Fax |
|
| Email |
abinash.mohapatra@kids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjukta Panda |
| Designation |
PhD Scholar |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
| Address |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University, Campus - 5, Patia Bhubaneswar - 751024, Odisha
ORISSA
751024
India |
| Phone |
09438166683 |
| Fax |
|
| Email |
sanjukta.panda@kids.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
|
|
Primary Sponsor
|
| Name |
DR SANJUKTA PANDA |
| Address |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SANJUKTA PANDA |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sanjukta panda |
Kalinga Institute of Dental Sciences, KIIT Deemed to be University |
DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY ROOM NO 9 9R27+59P, Campus 15 Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
9438166683
sanjukta.panda@kids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy indiviuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
evaluation of different school health education methods |
To evaluate the efficacy of school based oral health strategies in improving childrens oral health knowledge and behaviours |
| Comparator Agent |
Traditional classroom lectures conducted by teachers. |
.Intervention Duration and Structure:
The total duration of this intervention is 90 days, consisting of monthly 30-minute lectures. These lectures will focus on the importance of oral health, covering key topics such as proper brushing techniques, the impact of diet on dental health, and the prevention of common oral diseases. The sessions will be informational in nature, with no demonstrations or interactive activities included, allowing students to absorb critical health information in a focused, lecture-based format. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between 7- and 9-year-old age group enrolled in government school
2. Mixed dentition
3. Children who were positive and definitely positive according to Wright’s Modification of Frankl Behaviour rating scale
|
|
| ExclusionCriteria |
| Details |
1. Handicapped children; children with major debilitating illnesses and mentally retarded
2. Children undergoing prior dental treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improve in oral health conditions |
within 3months slight improvementwas observed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mild improvement in oral health conditions by using different methods of education |
3months |
|
|
Target Sample Size
|
Total Sample Size="396"
Sample Size from India="396"
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
Modification(s)
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The trial evaluating different oral health school education programs typically aims to assess the effectiveness of various educational interventions in improving oral health knowledge, attitudes, and behaviors among school-aged children. The background for such trials often includes concerns about poor oral health, including high rates of tooth decay and gum disease in children, which can have long-term consequences on their overall health, education, and well-being. Purpose of the trial:
The purpose is to compare different approaches to oral health education in schools—such as classroom-based lessons, hands-on activities, or digital resources—to determine which method most effectively promotes positive oral health behaviors (like regular brushing and dental visits) and increases knowledge about oral hygiene. By evaluating these programs, the trial seeks to identify best practices that can be widely implemented in schools to reduce oral health issues and foster lifelong habits that support good oral health. |