| CTRI Number |
CTRI/2025/07/090364 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Co-relation between screen time and TMJ pain |
|
Scientific Title of Study
|
Effect of screen time on TMJ pain :an observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS , Manipal |
| Address |
Department of Oral Surgery ,
MCODS , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
anand.shukla@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS , Manipal |
| Address |
Department of Oral Surgery ,
MCODS , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
anand.shukla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrAnand deep Shukla |
| Designation |
Associate Professor |
| Affiliation |
MCODS , Manipal |
| Address |
Department of Oral Surgery ,
MCODS , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742354052 |
| Fax |
|
| Email |
anand.shukla@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences , Manipal |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NA |
| Type of Sponsor |
Other [NA ] |
|
|
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 |
| DrAnand |
MCODS , Manipal |
MCODS , Manipal
Udupi district
Karnataka
576104
Udupi
KARNATAKA |
9742354052
anand.shukla@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital , Institutional Ethics Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TMJ PAIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18 -40 years
2. Patients experiencing TMJ pain for more than 2 weeks persistently .
3. Patients who agreed to be a part of the study .
|
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of trauma .
2. Patient suffering from serious medical conditions
3. Patients suffering from TMJ arthritis
4. Patients who do not wish to be a part of the study
5. having a diagnosis of systemic, metabolic neurological, or immune disorder or disease.
6. Patients who cant read English
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| : Association of TMJ symptoms and screen time shall be assessed in this study . |
Assessed at 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="329"
Sample Size from India="329"
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)
|
01/08/2025 |
| 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="1"
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
|
Screen
time is constantly increasing in todays population . An increase in the
prevalence of TMJ pain is also seen . once the patient comes with the problem
of TMJ pain , screen time is one factor which is often not taken into
consideration . This study is an attempt to co-relate the screen time and its
association with increasing TMJ pain especially amongst student population . Association of TMJ
symptoms and screen time shall be assessed in this study.
|