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CTRI Number  CTRI/2025/03/082764 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 15/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Better Oral Health for Children: New Tracking Tool vs. Traditional Teaching Methods" 
Scientific Title of Study   Comparative evaluation of a novel oral health tracker cum motivator and conventional oral health education method for improving oral health behavior among 10 to 15 years old school children in Lucknow -A randomized control 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  Deepak S 
Designation  MDS student 
Affiliation  king georges medical university 
Address  Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Lucknow
UTTAR PRADESH
226003
India 
Phone  08508958470  
Fax    
Email  deepaksbds.97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Gaurav Mishra 
Designation  Additional Proffesor 
Affiliation  king georges medical university 
Address  Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Lucknow
UTTAR PRADESH
226003
India 
Phone  9651771144  
Fax    
Email  gauravmishra@kgmcindia.edu  
 
Details of Contact Person
Public Query  
Name  Deepak S 
Designation  MDS student 
Affiliation  king georges medical university 
Address  Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Lucknow
UTTAR PRADESH
226003
India 
Phone  08508958470  
Fax    
Email  deepaksbds.97@gmail.com  
 
Source of Monetary or Material Support  
King Georges Medical University 
 
Primary Sponsor  
Name  King Georges Medical University 
Address  Department of public health dentistry, 2nd floor, old dental building,shah mina road, chowk, lucknow,UP,India, 226003 
Type of Sponsor  Government 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 
Deepak S  king georges medical university,  Department of Public Health Dentistry, Old Dental Building, King Georges Medical University, 2nd floor, Shah Mina Rd, Chowk, Lucknow—226003.
Lucknow
UTTAR PRADESH 		 08508958470

deepaksbds.97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, KGMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School Children of age 10-15 years in Lucknow 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparator agent  Traditional oral health education methods refer to conventional approaches used to teach children about maintaining good oral hygiene and dental care for 1 month  
Intervention  Intervention  Novel Table-Top Oral Health Tracker cum motivator which helps to track their oral health status daily for 1 month and also helps to gain knowledge regarding oral health 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. 10- to 15-year-old School children.
2. Written informed consent obtained from parents or legal guardians.
3. Students willing to participate in the study.
 
 
ExclusionCriteria 
Details  1. Students with severe cognitive or learning disabilities.
2. Students with severe dental conditions requiring immediate medical attention.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of the Oral Health Tracker with traditional oral health education methods  At baseline, 1month interval. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the improvement of knowledge and attitude among school children after using oral health tracker  At baseline, 1month interval 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/04/2025 
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  

In this randomized controlled trial, we will enroll a total of 60 10- to 15-year-old school children in Lucknow, randomly assigning 30 participants to the Oral Health Tracker Group and 30 to the Conventional Education Group. Baseline assessments of oral health knowledge, attitude and practice and oral health will be conducted for all participants through self-made 15 close ended questionnaire and debris part of OHI-S index. The Oral Health Tracker Group will receive oral health education using the novel table-top Oral Health Tracker cum motivator, while the Conventional Education Group will receive traditional oral health education method. Post-intervention assessments will be carried out through the same questionnaire and the debris index, and data will be analyzed to compare the effectiveness of the two educational approaches, adhering to ethical considerations and reporting guidelines. This study aims to provide insights into improving oral health awareness and practices among intermediate school children in Lucknow city.
 
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