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CTRI Number  CTRI/2023/03/050857 [Registered on: 20/03/2023] Trial Registered Prospectively
Last Modified On: 13/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [oral health education]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   effect of educational mobile messages on mothers knowledge level about their childs oral health. 
Scientific Title of Study   Effectiveness of educational WhatsApp messages compared to conventional oral health education on mother’s knowledge, perception and practices of their child’s oral health in Belagavi City- A Randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anu Sara Varghese 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti 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

Belgaum
KARNATAKA
590010
India 
Phone  9901193736  
Fax    
Email  anusv1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anu Sara Varghese 
Designation  Postgraduate student 
Affiliation  KAHER’s KLE Vishwanath Katti 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


KARNATAKA
590010
India 
Phone  9901193736  
Fax    
Email  anusv1995@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roopali Sankeshwari 
Designation  Professor 
Affiliation  KAHER’s KLE Vishwanath Katti 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

Belgaum
KARNATAKA
590010
India 
Phone  9844837197  
Fax    
Email  docrups@gmail.com  
 
Source of Monetary or Material Support  
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India  
 
Primary Sponsor  
Name  Anu Sara Varghese 
Address  Department number 2,Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India  
Type of Sponsor  Other [self funded] 
 
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 
Sr M Jisha OS  St. Bridgets kindergarten school  Nursery classroom, Ground floor, St. Bridgets kindergarten school, Vaibhav Nagar, Bauxite Road, Nehru Nagar P.O Belgaum 590010
Belgaum
KARNATAKA 		 8792014576

bridgetbelgaum@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  Mothers of 3-6 year old preschool children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Conventional Oral Health Education will be given to mothers at baseline. Reassessment after 4 months. 
Intervention  Intervention group  Educational WhatsApp messages will be sent fortnightly for 4 months. Reassessment will be done at the end of 4 months. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  mothers of 3-6 year old preschool children who accept to participate in all stages of research by signing a written informed consent form and those who have WhatsApp Messenger app installed on their smartphones, or those who agree to install it for participating in the study 
 
ExclusionCriteria 
Details  mothers of 3-6 year old preschool children who do not use smart phones 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
mother’s knowledge, perception and practices of their child’s oral health  Baseline, 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
oral health status of 3-6 year children  Baseline, 4 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/03/2023 
Date of Study Completion (India) 26/09/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Need for the study: 

Childhood oral health problems may result into the severe impairment of both general and oral health and as its prevalence in most of the countries is high it can be viewed as a relevant public health problem. Dental caries is a universally prevalent chronic disease and globally, around 486 million children suffer from caries of the primary teeth.

Children have a greater incidence of carious lesions as they reach school age, mostly due to irregular and ineffective oral hygiene habits and frequent snacking rich in carbohydrate and sugar. 

Family is the first institution that influences the child behaviour and development. Hence their health beliefs and attitude towards oral health care acts as a significant predictor of children’s oral health. By implementing the oral health care strategies involving the parents, it is hoped that the goal of having pre-school children free from oral diseases will become a reality one day.

Mobile health (mHealth) has enormous potential for conducting personalized approaches to disease prevention and management. 

Mobile devices allow low-cost interventions and are a means of providing individual level support to health care consumers in order to increase healthy behaviour.

Currently, WhatsApp Messenger (WhatsApp Inc.) is one of the most popular mobile apps worldwide, with approximately 300 million users. It has shown to be a promising tool for the communication between patients and professionals, aiding in the spread of health-related information. 

Therefore the present study aims to provide oral health education to mothers of preschool children in Belagavi city via WhatsApp messaging.

Hypothesis:

Null Hypothesis:

There is no difference between the impact of conventional oral health education and educational WhatsApp messages on  mother’s knowledge and practices of their child’s oral health.

Alternate Hypothesis:

There is a difference between the impact of conventional oral health education educational WhatsApp messages on mother’s knowledge and practices of their child’s oral health.

 Aim of the study:

To assess and compare the effectiveness of educational WhatsApp messages and conventional oral health education on mother’s knowledge and practices of their child’s oral health.

Objectives:

To assess and compare the knowledge, perception and practices of mothers regarding their child’s oral health before and after intervention in the experimental and control group.

To assess oral health status of preschool children before and after intervention in the experimental and control group.

Methodology

Selection of the study subjects will be done based on two stage sampling technique and subjects fulfilling inclusion and exclusion criteria will be considered.

Baseline assessment using Questionnaire followed by oral health education.

Educational Oral health messages  will be sent fortnightly for 4 months in the intervention group and conventional oral health education to the control group.

Reassessment after 4 months using same questionnaire.



 
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