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CTRI Number  CTRI/2025/05/087841 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   GAME-BASED TEACHING FOR TOBACCO CONTROL AMONG STUDENTS  
Scientific Title of Study   Effectiveness of Decoding Interactive Cognition-based Education (DICE) technique on the knowledge, attitude and practices of tobacco use and control among the dental undergraduates in Belagavi city: A randomized controlled trial 
Trial Acronym  DICE 
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  07092025278  
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  07092025278  
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


KARNATAKA
590010
India 
Phone  07092025278  
Fax    
Email  dranilankola@kledental-bgm.edu.in  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences, Nehru nagar, Belagavi 
 
Primary Sponsor  
Name  KLE VK Institute of Dental Sciences, Nehru nagar, Belagavi 
Address  JNMC Campus, Nehru nagar, Belagavi 
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 Apoorva S R  KLE VK Institute of Dental Sciences  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 		 07092025278

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 
Healthy Human Volunteers  Healthy without any systemic conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  classroom teaching  conventional one-way lecture will be given  
Intervention  Decoding Interactive Cognition-based Education (DICE) game-based learning  The model is inspired from snake and ladder. Whenever the dice is rolled, the player gets to move to the position when he answers the particular questions correctly, the player moves back a step when answered wrong 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Dental undergraduate students who give informed consent
Students available and willing to participate for the full duration of the study
 
 
ExclusionCriteria 
Details  Those who are not willing to participate or are unavailable during follow-up sessions 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There is a significant difference in the knowledge, attitude, and practices related to tobacco use and control among dental undergraduates after exposure to the DICE game technique compared to traditional teaching methods.  At baseline and after 21days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the knowledge & attitude & practices related to tobacco use & control among the study participants.   At baseline & after 21days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   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="0"
Days="21" 
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   Tobacco use is a leading preventable cause of morbidity and mortality in India, with high prevalence among young adults, including dental undergraduates. Despite existing legislation like COTPA, there remains a gap in knowledge, attitude, and practices (KAP) regarding tobacco use and control. This randomized controlled trial aimed to evaluate the effectiveness of the Decoding Interactive Cognition-based Education (DICE) technique compared to conventional teaching methods among dental undergraduates in Belagavi city. Participants were randomly assigned to either a control group, which received a 10–15-minute lecture-based session, or an intervention group, which engaged in a DICE game-based learning session that promoted interactive and critical thinking through gameplay and debriefing. KAP assessments were conducted at baseline, immediately post-intervention, and after 21 days. Findings revealed improvements in both groups, but the DICE group showed significantly greater and sustained gains in all three domains. The results suggest that the DICE technique is a more effective and engaging educational strategy for enhancing tobacco-related knowledge, shaping positive attitudes, and encouraging healthier practices among dental students. 
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