| CTRI Number |
CTRI/2025/05/087628 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Comparasion Study between the effects of powerpoint and Game based approach of teaching Oral Hygiene on two different age group participants to promote good Oral Health |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN THE EFFECTS OF
CONVENTIONAL AND GAME BASED APPROACH ON
ORAL HYGIENE STATUS ON TWO DIFFERENT AGE
GROUP CHILDREN-A PROSPECTIVE COHORT STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRITIKA PRASAD |
| Designation |
PG Student |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital, Patna, Bihar |
| Address |
Buddha Institute of Dental Sciences and Hospital,Department of Paediatric and Preventive Dentistry,Room no312,West of TV Tower,Gandhinagar,Kankarbagh,
Patna
Patna
BIHAR
800026
India |
| Phone |
8619970318 |
| Fax |
|
| Email |
kritikaprasad511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JN SHUKLA |
| Designation |
PROFESSOR |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital, Patna, Bihar |
| Address |
Buddha Institute of Dental Sciences,West of TV Tower,Gandhinagar,Kankarbagh,Patna
Patna
BIHAR
800026
India |
| Phone |
9415080770 |
| Fax |
|
| Email |
jeevshukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KRITIKA PRASAD |
| Designation |
PG Student |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital, Patna, Bihar |
| Address |
Buddha Institute of Dental Sciences and Hospital,Department of Paediatric and Preventive Dentistry,Room no 312,West of TV Tower,Gandhinagar,Kankarbagh,
Patna
Patna
BIHAR
800026
India |
| Phone |
8619970318 |
| Fax |
|
| Email |
kritikaprasad511@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Buddha Institute of Dental Science and Hospital |
| Address |
West of TV Tower, Gandhinagar, Kankarbagh, Patna, Bihar |
| Type of Sponsor |
Other [Private Dental Institute] |
|
|
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 |
| Kritika |
Buddha Institute of Dental Sciences and Hospital |
Room no 312,Department of Paediatric and Preventive Dentistry,West of TV Tower,Gandhi Nagar,Kankarbagh,Patna-800026
Patna
BIHAR |
8619970318
kritikaprasad511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC/BIDSH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with bad Oral Hygiene |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children who will be willing to participate in the study.
Normal and Medically fit children.
Children who will obtain informed voluntary written consent from their parents/guardian to participate in the study |
|
| ExclusionCriteria |
| Details |
Physically and mentally challenged children and children with systemic diseases.
Children missing more than one educational session |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Calculus and Debris Score |
Baseline, After 6 months, After 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2026 |
| 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="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
|
A total of 100 children will be randomly selected irrespective of their gender for this study. These 100 children will be divided into two equal groups Gr I & Gr II of 50 children each. Group I will be explained by conventional method i.e power point presentation including videos on oral hygiene. Group II will be explained by game based approach of oral hygiene. These two groups will be further sub divided into 2 sub groups i.e Group IA & Gr IB, Gr IIA & Gr IIB. Group I A will include 25 children of 4 to 6 years of age group. Group I B will include 25 children of age group of 9 to 11 years. Group II A will include 25 children of 4 to 6 years of age group. Group II B will include 25 children of age group of 9 to 11 years. Prior to the start of the study consent and assent will be obtained from parents & the children respectively for both the age groups. At the first visit, OHI-S index will be obtained from all children prior to the start of the study. All the children of different groups will be explained about oral hygiene awareness through conventional and game-based technique as per alloted. This procedure will be repeated once every month for a period of 1 year. After 1 year of oral hygiene awareness we will again record OHI-S index on the final visit. Both the OHI-S indices (pre & post) will be obtained, assimilated and sent for statistical analysis. |