| CTRI Number |
CTRI/2026/04/107352 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Assesment of oral health status among 11-12 year old school children in khordha district, odisha through cariogram using the Health Belief Model. |
|
Scientific Title of Study
|
Assessment of oral health status and computer-based caries risk in 11-12 year old school children in Khordha district, Odisha using the Health Belief Model. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Kotak |
| Designation |
Post Graduate Trainee (PGT) |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
09732616645 |
| Fax |
|
| Email |
princakotak66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSourav Chandra Bidyasagar Bal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861811619 |
| Fax |
|
| Email |
generationx.sourav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSourav Chandra Bidyasagar Bal |
| Designation |
Associate Professor |
| Affiliation |
Institute of Dental Sciences, Bhubaneswar |
| Address |
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9861811619 |
| Fax |
|
| Email |
generationx.sourav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Science |
| Address |
Institute of Dental Sciences, Sum Hospital, Kalina Nagar, Pin code - 751003 |
| 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 |
| DRPriyanka Kotak |
INSTITUTE OF DENTAL SCIENCES |
Room number 9
Department of Public Health Dentistry
Institute of Dental Sciences
Kalinga nagar, Bhubaneswar
Khordha
ORISSA |
08918048996
princakotak66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-INSTITUTE OF DENTAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Oral Health Education |
A powerpoint presentation on conventional oral health education would be provided to the control group. It will be done 3 months after baseline data completion. |
| Intervention |
Health Belief Model. |
Health Belief Model powerpoint presentation will be shown to the intervention group which would have examples from routine dental practices.
It will be a one time intervention which will be done 3 months after baseline data collection |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All those children from whom infromed consent could ne obtained from parents and school teachers. |
|
| ExclusionCriteria |
| Details |
Those who denied informed consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Constructs of HBM |
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caries risk and oral health status |
baseline and followup (0 month and 11 month) |
|
|
Target Sample Size
|
Total Sample Size="748"
Sample Size from India="748"
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)
|
13/04/2026 |
| 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="11"
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 - NO
|
|
Brief Summary
|
Assessment of oral health status and caries risk in 11 and 12 year old school children in Khordha district orissa To assess the effectiveness of Health Belief Model on oral health status and caries risk and to commute changes in plaque and dental caries using Cariogram Sample size was calculated out to be 748 |