| 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
|
|
|
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
|
|
|
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
|
|
|
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. |