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