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CTRI Number  CTRI/2025/11/098177 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fun learning through the “Smile and Climb” board game and “Smile Safari” crossword to improve oral health awareness and habits among children. 
Scientific Title of Study   Innovative Tools Like Smile and Climb Board Game and Smile Safari Crossword Enhancing Oral Health Knowledge and Practices : A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Sidhyesh  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sidhyesh Aviansh Baviskar 
Designation  Pediatric dentistry resident 
Affiliation  Peoples College of Dental Sciences 
Address  Peoples college of dental sciences bhanpur bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9404671685  
Fax    
Email  sidhyeshbaviskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sidhyesh Aviansh Baviskar 
Designation  Pediatric dentistry resident 
Affiliation  Peoples College of Dental Sciences 
Address  Peoples college of dental sciences bhanpur bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9404671685  
Fax    
Email  sidhyeshbaviskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sidhyesh Aviansh Baviskar 
Designation  Pediatric dentistry resident 
Affiliation  Peoples College of Dental Sciences 
Address  Peoples college of dental sciences bhanpur bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9404671685  
Fax    
Email  sidhyeshbaviskar@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry Peoples College of Dental Sciences and Research Centre, Bhopal, India 462037 
 
Primary Sponsor  
Name  Peoples College of Dental Sciences and Research Centre Bhopal India 
Address  Department of Pediatric and Preventive Dentistry Peoples College of Dental Sciences and Research Centre, Bhopal, India 462037 
Type of Sponsor  Research institution and hospital 
 
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 Archna iyyer  Podar international school  bhanpur, bhopal
Bhopal
MADHYA PRADESH 		 7999467704

iterarchna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Peoples College of Dental Sciences & Research Centre Peoples University Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Oral health knowledge, attitudes, and practices among children; prevention of dental caries and plaque accumulation. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Smile and Climb Board Game  Traditional oral health education session followed by the Smile and Climb Board Game activity conducted once weekly for 4 weeks (each session approximately 30 minutes). 
Intervention  Smile Safari Crossword Puzzle  Traditional oral health education session followed by the Smile Safari Crossword Puzzle activity conducted once weekly for 4 weeks (each session approximately 30 minutes). 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 6–12 years

Healthy children with no relevant medical history 
 
ExclusionCriteria 
Details  Children with cognitive, vision, hearing, or developmental impairments 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Improvement in oral health knowledge, attitude, and practices among children aged 6–12 years  At baseline (Day 0) and after 7 days (Post-intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Oral Hygiene Index (OHI) scores  Baseline (Day 0), 4 weeks, & 8 weeks after intervention 
Change in Plaque Index (PI) scores  Baseline (Day 0), 4 weeks, & 8 weeks after intervention 
Reduction in Dental Anxiety Levels  Baseline (Day 0), 4 weeks, & 8 weeks after 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)   10/12/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  De-identified participant data (questionnaire responses, oral hygiene scores, plaque index scores) may be shared upon reasonable request after completion of the study, subject to Institutional Ethics Committee approval.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  De-identified participant data (questionnaire responses, oral hygiene scores, plaque index scores) may also be shared upon reasonable request.
  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response (Others) -  Data will be available for analyses aimed at achieving the objectives outlined in the approved proposal and for inclusion in individual participant data (IPD) meta-analyses.

  5. By what mechanism will data be made available?
    Response (Others) -  Access will be granted upon signing a data access agreement and after approval from the Institutional Ethics Committee. Data will be shared through secure transfer mechanisms.

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 02-02-2027?
    Response (Others) -  Data will be available from 02/01/2026 to 02/02/2027 (1 year after study completion and publication).

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No public repository available. De-identified data will be shared only upon request and subject to Ethics Committee approval.
Brief Summary   This randomized controlled trial aims to assess the effectiveness of innovative educational tools—the Smile and Climb Board Game and the Smile Safari Crossword Puzzle—in enhancing oral health knowledge, attitudes, and practices among children aged 6–12 years. Ninety children will be randomly allocated to three groups: control (traditional education), intervention 1 (traditional education + board game), and intervention 2 (traditional education + crossword). Outcomes will be measured using a Knowledge–Attitude–Practice questionnaire, Oral Hygiene Index, and Plaque Index before and after a 7-day intervention. The findings are expected to provide evidence for gamification as an effective oral health education strategy. 
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