| CTRI Number |
CTRI/2020/02/023535 [Registered on: 24/02/2020] Trial Registered Retrospectively |
| Last Modified On: |
24/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of WhatsApp based oral health education in the improvement of oral health among the college students in Chennai |
|
Scientific Title of Study
|
Effectiveness of Social Media Based Oral Health Promotion Programme Among College Students in Chennai- An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedha Subburaman |
| Designation |
Post Graduate Student |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Room No 10
Department of Public Health Dentistry
Ragas Dental College and Hospital
2/102, East Coast Road, Uthandi, chennai-119
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
nivedha4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PDMadankumar |
| Designation |
Professor and Head |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Department of Public Health Dentistry
Ragas Dental College and Hospital
2/102, East Coast Road, Uthandi, chennai-119
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
madankumar21@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nivedha Subburaman |
| Designation |
Post Graduate Student |
| Affiliation |
Ragas Dental College and Hospital |
| Address |
Room no 10
Department of Public Health Dentistry
Ragas Dental College and Hospital
2/102, East Coast Road, Uthandi, chennai-119
Kancheepuram
TAMIL NADU
600119
India |
| Phone |
9566017103 |
| Fax |
|
| Email |
nivedha4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ragas Dental College and Hospital
2/102, East Coast Road, Uthandi, chennai-119 |
|
|
Primary Sponsor
|
| Name |
Nivedha Subburaman |
| Address |
Plot 4 Kubernagar main road, opp 7th street, Kubernagar extension, madipakkam, Chennai-91 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Nivedha Subburaman |
D.G.Vaishnav College of Arts and Science |
833, E.V.R. Periyar High Road, Arumbakkam, Chennai, Tamil Nadu 600106
Chennai
TAMIL NADU |
9566017103
nivedha4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Ragas Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers who donot have any systemic illness and are not under any medication are included for the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
The control Group consist of 70 participants who will not be included in the WhatsApp Group. After the Initial phase of Oral Health Education given to all the participants at the baseline, the participants in the control group shall restrained from any form of health education by the chied Investigator, thereafter. They will be followed up for a period of six months (October 2017 to April 2018). |
| Intervention |
Oral Health Education using Whatsapp Application Group |
The intervention group consist of 70 participants from First Year, Second Year Under Graduation and First Year Post Graduation. All the participants will be included in the mobile application –WhatsApp Group. Individual Groups will be created for each class. Separate groups will be created for Boys and Girls in every class, considering the request proposed by the college authority. 2 class teachers will also be included in every group to monitor the activities of the students. The intervention will be provided by the chief examiner based on literature search and findings from previous studies on interventions through oral health education. The messages will be delivered to the participants in the form of textual messages, pictorial illustrations or audio-visual education once/twice every week for a period of three months. Any doubts/clarifications/queries will be sorted out to the participants via conversations and discussions within the group. The intervention comprised of three major concepts spread over three months (October 2017 – April 2018) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
2. Participants with baseline OHI-S score and Modified Gingival Index score more than 1.
3. Participants who are not suffering from any apparent systemic illness/disease.
4. Participants who have sound knowledge in the use of WhatsApp application technology.
|
|
| ExclusionCriteria |
| Details |
1. Participants who did not wish to give consent.
2. Participants who suffered from acute infectious dental conditions.
3. Participants who underwent/undergoing orthodontic treatment.
4. Participants who underwent dental procedures 3 months prior to the start of the study and thereafter.
5. Participants who were under medication for any systemic illness.
6. Participants who have visual/ hearing impairment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Oral Hygiene Index -
Simplified (John.C. Greene and Jack. R. Vermillion, 1964)
2. Modified Gingival Index (Lobene et al.)
|
Baseline (October 2017), First(November 2017), Third(January 2018) and Sixth(April 2018) month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. Knowledge, Attitude and Practice towards oral health was assessed using the pre-tested questionnaire by Santosh kumar et al. |
baseline(October 2017) and sixth(April 2018) month |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/12/2017 |
| Date of Study Completion (India) |
20/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
PUBLICATION WILL BE CARRIED OUT AFTER THE TRIAL GETS COMPLETED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was designed to assess and compare the effectiveness of social media based health education (using WhatsApp mobile application) on the oral health status of the college students in Chennai. Two hundred and fifty students will be screened and one hundred and forty students who met the inclusion and exclusion criteria will be randomly allocated to the intervention and the control group. The level of WhatsApp addiction among the students will be assessed using the WhatsApp Addiction Scale. The Oral Health Status of students in both the groups shall be assessed using Simplified Oral Hygiene Index (John.C. Greene and Jack. R. Vermillion, 1964) and Modified Gingival Index (Lobene et al.). Also, data regarding the Knowledge, Attitude, and Practice towards oral health will be collected using a pre-tested questionnaire by Santosh Kumar et al. Oral health education shall be provided to all the students using various methods such as lecture, peer teaching and demonstrations using tooth models and other oral health education aids. The control group would be restrained from any form of oral health education, thereafter. The intervention will be given to the interventional group through the social networking application called Whatsapp– which aimed at providing oral health education through picture, video and text messages to improve the Oral Health Status. After baseline examination, the intervention will be given at the first, second and thirdmonth.. Follow up examinations will be carried out among both the groups at the third and the sixth month. Oral Health Status will be assessed using Simplified Oral Hygiene Index (John.C. Greene and Jack. R. Vermillion, 1964) and Modified Gingival Index (Lobene et al.). Also, their knowledge, Attitude, and Practice towards oral health will be assessed again using the pre-tested questionnaire by Santosh Kumar et al. The time frame for the study will be six months. |