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CTRI Number  CTRI/2025/05/087666 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 26/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Comparing the effectiveness of Conventional lecture-based oral health education and group discussion-based oral health education 
Scientific Title of Study   Comparative Evaluation of Active Peer Teaching technique and Lecture-based Oral Health Education on Knowledge, Awareness, Practices, and Oral hygiene status among 12-15year old School children in Belagavi city: A Cluster randomized controlled 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  Dr Apoorva S R 
Designation  Postgraduate student 
Affiliation  KAHERS KLE VK Institute of dental sciences 
Address  Department number 2, Public Health Dentistry, Ground floor, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India

Belgaum
KARNATAKA
590010
India 
Phone  7092025278  
Fax    
Email  apoodheez10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil V Ankola 
Designation  Professor 
Affiliation  KAHERS KLE VK Institute of dental sciences 
Address  Department number 2, Public Health Dentistry, Ground floor,KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India

Belgaum
KARNATAKA
590010
India 
Phone  9343434455  
Fax    
Email  dranilankola@kledental-bgm.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Anil V Ankola 
Designation  Professor 
Affiliation  KAHERS KLE VK Institute of dental sciences 
Address  Department number 2, Public Health Dentistry, Ground floor,KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi 590010, Karnataka, India

Belgaum
KARNATAKA
590010
India 
Phone  9343434455  
Fax    
Email  dranilankola@kledental-bgm.edu.in  
 
Source of Monetary or Material Support  
Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr Apoorva S R 
Address  Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India 
Type of Sponsor  Other [Self ] 
 
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 Apoorva S R  KLES International school, Belagavi  Class VI to IX, Divisions A to E, Ground floor, Room Number 4 to 7, Department of secondary education, KLES International school, No 40, Kuvempu nagar, Belagavi-590010
Belgaum
KARNATAKA 		 7092025278

apoodheez10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active peer teaching technique  This technique uses a modification of jigsaw group discussion in which topics are assigned to around 6 groups with about 5 students in each group using a lottery method. Each group prepares their assigned topic using a booklet designed by a graphic designer and other available resources. Subsequently, the groups are shuffled to form new groups, ensuring that each new group has at least one member from each initial topic group to cover all topics comprehensively. Members share their findings within the new groups using methods developed by the primary investigator which will be determined by a lottery method. Frequency will be for one time. Total duration of the intervention will be for 15minutes to 20minutes 
Comparator Agent  Conventional lecture-based oral health education through powerpoint presentations  Conventional Oral health education will be given in front of school experts for smooth delivery oral health education at Baseline. Frequency is for one time. Total duration will be for 15minutes to 20minutes. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Children aged 12-15 years attending English-medium schools.
2. Children who accept to participate in all stages of research by signing a written informed consent form.
3. Children with mild to moderate gingivitis with a maximal gingival score of 2.
 
 
ExclusionCriteria 
Details  1. Children who decline to participate or withdraw consent at any point during the study.
2. Children who are severely ill, or with any systemic disease.
3. Children who are under medications/undergone any dental treatment in the past 6 months that might alter their gingival status.
 
 
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   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in knowledge, awareness, practices and oral hygiene status   baseline, immediately post-intervention and after 3months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in tooth brushing efficacy  Baseline and 3 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   Phase 3 
Date of First Enrollment (India)   01/07/2025 
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="3"
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 need for this study arises from the increasing concern over poor oral hygiene among schoolchildren, which can lead to long-term dental issues. By comparing two teaching techniques, this research seeks to identify more effective strategies for improving children’s oral health education, which could lead to better knowledge retention and healthier habits, benefiting both short-term and long-term oral hygiene outcomes.This study aims to compare the effectiveness of Active Peer Teaching and lecture-based oral health education on 12-15 year-old schoolchildren in Belagavi city. It assesses their knowledge, awareness, practices, and oral hygiene status before and after the intervention. The control group receives a traditional 30-minute lecture on oral health, followed by a demonstration and post-assessment, with a follow-up after three months. The intervention group, using Active Peer Teaching, engages in group activities where students prepare and share information on oral health. Both groups are evaluated at baseline, post-intervention, and after three months to measure changes. 
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