| CTRI Number |
CTRI/2022/09/045472 [Registered on: 13/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Comic book vs comic video in Educating tooth brushing habits among school children |
|
Scientific Title of Study
|
Effectiveness of Comic book vs comic video in refining tooth brushing habits and plaque scores among primary school children-A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yerra Rupa Rani |
| Designation |
final year Post graduate student |
| Affiliation |
sri sai college of dental surgery |
| Address |
Room No 2 Department of public health dentistry Sri sai college of dental surgery Vikarabad
Hyderabad TELANGANA 500028 India |
| Phone |
8555015398 |
| Fax |
|
| Email |
ruparaniyerra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yerra Rupa Rani |
| Designation |
Final year Post graduate student |
| Affiliation |
sri sai college of dental surgery |
| Address |
Room No 2 Department of public health Dentistry Sri Sai College of dental surgery Vikarabad
Hyderabad TELANGANA 500028 India |
| Phone |
8555015398 |
| Fax |
|
| Email |
ruparaniyerra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yerra Rupa Rani |
| Designation |
final year Post graduate student department of public dentistryhealth |
| Affiliation |
sri sai college of dental surgery |
| Address |
Room No 2 Department of public health Dentistry Sri Sai College of dental surgery Vikarabad
Hyderabad TELANGANA 500028 India |
| Phone |
8555015398 |
| Fax |
|
| Email |
ruparaniyerra@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri sai college of dental surgery |
|
|
Primary Sponsor
|
| Name |
Sri Sai College of Dental Surgery |
| Address |
Room No 2 Department of public health Dentistry Sri Sai College of dental surgery Vikarabad |
| 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 |
| Dr P Krishnajaneya Reddy |
sri sai college of dental surgery |
Room No 2 Department of public health Dentistry Hyderabad TELANGANA |
9849995613
drkrishreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
Traditional method of dental education.
Frequency is twice and
Duration is 2 months |
| Intervention |
Dental education |
Group1 comic book education
Group2 comic video education
Frequency of intervention is twice, duration of the study is 2 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Those who were present on the day of intervention met the criteria. |
|
| ExclusionCriteria |
| Details |
1. Children visiting a dentist regularly or receiving dental health education through another source
2. physically or mentally or medically compromised children were excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PLAQUE SCORES |
plaque scores will be recorded at baseline and 6 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| tooth brushing habits |
improvement in tooth brushing habits 6 weeks after providing intervention |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
15/09/2022 |
| 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="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the critical factors in maintaining good oral health is proper oral hygiene practices. Intervention given in the formative years of the child will be there for a lifetime. The oral health status of the children may be improved if health education in schools is conducted in a comprehensive and interesting manner. The aim of the study is to assess the effectiveness of comic books vs comic videos in refining tooth brushing habits and plaque scores among primary school children. 90 primary school students aged 7-9 years from three different primary schools will be included in this study. Schools will be randomly assigned as a comic book group, a comic video group, and a control group which will be provided with the traditional method of teaching tooth brushing habits. All the 3 groups will be provided with toothbrushes and toothpaste. Baseline plaque scores will be recorded and after 6 weeks post-intervention plaque scores will be recorded along with tooth brushing habits to see the effectiveness of the two interventions. Collected data will be subjected to descriptive statistics and normality tests will be performed based on the type of data distribution appropriate statistical tests will be applied. |