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CTRI Number  CTRI/2025/05/087039 [Registered on: 16/05/2025] Trial Registered Prospectively
Last Modified On: 16/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of mobile application on oral health and nutrition of children aged between 8-12 years based on thinking ablity in Tumakuru district 
Scientific Title of Study   Impact of mobile platform on Oral health status and Nutritional status of children aged between 8-12 years based on Intelligent Quotient and Self concept in rural and urban areas in Tumakuru 
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 Maheshkumar K 
Designation  Assistant Professor 
Affiliation  Sri Siddhartha Dental College and Hospital 
Address  Room no: 6 Department of Pedodontics Sri Siddhartha Dental College and Hospital B.H.Road Agalakote,Tumkuru
Room no: 6 Department of Pedodontics Sri Siddhartha Dental College and Hospital B.H.Road,Agalakote,Tumkuru.
Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Maheshkumar K 
Designation  ASSITANT PROFESSOR 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE AND HOSPITAL 
Address  Room no :6 Department of pedodontics Sri Siddhartha dental college and hospital ,B.H.Road,Agalakote tumkur.
B.H. ROAD ,AGALAKOTE , TUMAKUR 572107
Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Maheshkumar K 
Designation  ASSITANT PROFESSOR 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE AND HOSPITAL 
Address  Room no :6 Department of pedodontics Sri Siddhartha dental college and hospital ,B.H.Road,Agalakote tumkur.
B.H. ROAD ,AGALAKOTE , TUMAKUR 572107
Tumkur
KARNATAKA
572107
India 
Phone  7010950226  
Fax    
Email  kmaheshkumarbds@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr K Maheshkumar 
Address  Room no :6 Department of pedodontics Sri Siddhartha dental college and hospital ,B.H.Road,Agalakote tumkur,Karnataka,india. Pin code - 572107 
Type of Sponsor  Other [Am the PhD student am the primary sponsor for this reasearch ] 
 
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 MAHESH KUMAR K  Sri Siddhartha Dental College and Hospital  Room no :6 Department of pedodontics Sri Siddhartha dental college and hospital,B.H.Road,Agalakote tumkur.
Tumkur
KARNATAKA 
7010950226

kmaheshkumarbds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SIDDHARTHA DENTAL COLLEGE HOSPITAL INSTITUTIONAL ETHICAL COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children 8-12 years of age.
2. Children belonging to middle socioeconomic class on the basis of Revised Modified BG Prasad socioeconomic classification scale, 2023
 
 
ExclusionCriteria 
Details  1. Children with local factors that can affect gingival health, like lip incompetence, mouth breathing, orthodontic appliances, cleft lip/palate.
2. Children with visual, hearing or speech impairment, with systemic diseases and developmental disorders.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out the correlation between the IQ and self concept level on oral health status and nutritional status of children aged between 8-12 years  6 months- Evaluating IQ Level and self respect
6 Months - 1 Year - Developing Mobile appplication

2-4 YEAR- FOLLOW UP (Evaluating oral health status and nutritional status) 
 
Secondary Outcome  
Outcome  TimePoints 
use of smart phone application which helps in better management of childrens diets & increase awareness about healthy eating habits improving oral & nutritional health of children, especially when tailored to their IQ & self-concept.
 
2 years - will evaluate the outcome oral health status & nutrition status after using mobile application  
 
Target Sample Size   Total Sample Size="420"
Sample Size from India="420" 
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)   02/06/2025 
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="3"
Months="0"
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 - NO
Brief Summary  

The WHO estimates that globally close to 3.5 billion people (approximately 50% of population) suffer from one or the other form of oral disease. The prevalence of dental caries was found to be 48.8%. A total of 54.6% of students were malnourished, and 47.7 % were underweight for their age 3–18-year-old Indian School-going Children.1

The concept of oral health involves the interaction between genetic and environmental factors in which biological, social, behavioural and psychological components are expressed in a highly complex and interactive manner. intelligence quotient and self-concept which are two major psychological parameters designing character of the children might affect oral health status and nutritional status.2

In the current era of digital revolution, mobile apps have found their utility in several aspects of managing people’s health and wellness. Smartphone apps can be a valuable tool for health promotion, as they are more likely to be accepted by young children than traditional means of oral health education.as present generation are more mobile friendly.3

There are no studies in the literature targeting pre adolescent  children,  educating  using mobile application to improve the  oral health status and nutritional status which is very crucial during this age  as they are growing faster and becoming more independent.  The impact of the habit cultivated during this age  will definitely have a long lasting effect.

             Hence the present study is to evaluate impact of mobile  platform  and conventional method (Charts and Booklets) on oral health status and nutritional status of children aged between 8-12 years based on intelligence quotient and self concept in rural and urban areas of tumakuru.

 
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