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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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