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CTRI Number  CTRI/2020/04/024409 [Registered on: 01/04/2020] Trial Registered Prospectively
Last Modified On: 31/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [Effectiveness of mHealth on tooth brushing technique and oral health behaviour ]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of health education using mobile application on Tooth Brushing Technique and Oral Health Behaviour among the adolescents as compared to conventional health education method: A cluster RCT. 
Scientific Title of Study   Effectiveness of mHealth on Tooth Brushing Technique and Oral Health Behaviour among the adolescents: A cluster RCT. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gargi Nimbulkar  
Designation  Assistant Professor 
Affiliation  DMIMS(DU) 
Address  301 Department of Public Health Dentistry,Sharad Pawar Dental College ,Datta Meghe Institute of Medical sciences, Sawangi (Meghe),Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9421703449  
Fax    
Email  garginimbulkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gargi Nimbulkar  
Designation  Assistant Professor 
Affiliation  DMIMS(DU) 
Address  301 Department of Public Health Dentistry,Sharad Pawar Dental College ,Datta Meghe Institute of Medical sciences, Sawangi (Meghe),Wardha


MAHARASHTRA
442001
India 
Phone  9421703449  
Fax    
Email  garginimbulkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gargi Nimbulkar  
Designation  Assistant Professor 
Affiliation  DMIMS(DU) 
Address  301 Department of Public Health Dentistry,Sharad Pawar Dental College ,Datta Meghe Institute of Medical sciences, Sawangi (Meghe),Wardha


MAHARASHTRA
442001
India 
Phone  9421703449  
Fax    
Email  garginimbulkar@gmail.com  
 
Source of Monetary or Material Support  
Self funded 
 
Primary Sponsor  
Name  Dr Gargi Nimbulkar  
Address  301 ,Department of Public Health Dentistry ,Sharad Pawar Dental College , DMIMS(DU) 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prasanna zade  Engineering college  Datta Meghe Institute of Engineering, Technology & Research, Wardha
Wardha
MAHARASHTRA 
9673321177

zadepl@gmail.com 
Dr Waquar Naqui  Physiotherapy college  Ravi Nair Physiotherapy college, DMIMSU Campus, Sawangi Meghe, Wardha, Maharashtra 442004
Wardha
MAHARASHTRA 
902169000

waqar.naqvi@dmimsu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DMIMS/IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional method of oral health education  Oral health education in the form of demonstration and audio aids 
Intervention  mhealth  Oral health education with the help of mobile app 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  The participants should possess smart phone with accessibility to internet. The adolescent with plaque index score of one or more than one such be included in the Turesky-Gilmore-Glickman Modification of the Quigley Hein Plaque Index and adolescent with plaque induced gingivitis are included in the gingival index given by Loe H and Silness J. 
 
ExclusionCriteria 
Details  Those who are undergoing orthodontic treatment and participants who are mentally or physically disabled will be excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in plaque index and gingival index and oral hygiene habits  baseline, 1 month , 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Oral hygiene habits  3 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/04/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The present study will be conducted by the department of Public Health Dentistry, Sharad Pawar Dental College, Sawangi. Inclusion Criteria : Age- 17-19 years. Moderate gingivitis and fair plaque score as measured by gingival index and plaque index. Exclusion criteria: Not willing to participate in the study. Prepared questionnaire will be solved by the selected subjects. If required, the investigator will help in understanding the questions to the selected subjects. The two groups will be: Group A- mhealth intervention for oral health education, Group B- conventional oral health education. The mhealth intervention includes oral health education by conventional method using placards and demonstration along with informative messages on mobile application. The details about the oral hygiene practice of the adolescent, the method of brushing, the ill effects of poor oral hygiene and their previous dental visits if any for both the groups will be recorded. The mHealth  means the mobile application will be used that contain the details about the oral hygiene practices required that includes the proper brushing technique , the method of brushing and the consequences of improper oral hygiene. The other group will given oral health education by conventional method using placards and demonstration. The questionnaire will be used to evaluate and compare knowledge pre and post intervention at baseline, 1 month and 3 months. The oral hygiene will be evaluated through the Turesky-Gilmore-Glickman Modification of the Quigley Hein Plaque Index and gingival Index given by Loe H and Silness J at baseline, 1 month and 3 months. 
 
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