| CTRI Number |
CTRI/2019/05/019368 [Registered on: 27/05/2019] Trial Registered Prospectively |
| Last Modified On: |
29/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stress hormone levels in students with ear pain |
|
Scientific Title of Study
|
Assesment of salivary cortisol as stress marker in undergraduate dental and medical students with temporomandibular disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chung Luo Wei |
| Designation |
Dental Student |
| Affiliation |
Faculty of dentistry,Melaka Manipal Medical college |
| Address |
Room no 506,5th foor,Faculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
room no 506,5th floor,Faculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
9902781690 |
| Fax |
|
| Email |
luowei96@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapna B V |
| Designation |
Associate Professor |
| Affiliation |
Faculty of dentistry,Melaka Manipal Medical college |
| Address |
Department of prosthodontics, 5th Floor,Faculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
Department of prosthodontics, 5th FloorFaculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
9880359889 |
| Fax |
|
| Email |
swapna.bv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chung Luo Wei |
| Designation |
Dental Student |
| Affiliation |
Faculty of dentistry,Melaka Manipal Medical college |
| Address |
Room no 506,5th floor,Faculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
Room no 506, 5th floor,Faculty of Dentistry,Melaka Manipal medical college,Manipal.
Manipal academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
9902781690 |
| Fax |
|
| Email |
luowei96@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Student seed Money,Manipal Academy of Higher Education,Manipal,Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education,Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Chung Luo Wei |
Faculty of Dentistry , Melaka Manipal Medical College |
Department of Prosthodontics, 5th floor,Faculty of Dentistry,Melaka Manipal Medical college ,Manipal ,Karnataka
Udupi
KARNATAKA |
9902781690
luowei96@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee,Kasturba medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
BDS and MBBS students of year I and II of Melaka Manipal Medical college, Manipal who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Smokers,
History of orthodontic treatment
History of systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of temporomandibular disorders (TMDs) among dental and medical undergraduate students |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary cortisol estimation will be done in students with TMD group. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
30/05/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A cross sectional study will be done among 400 dental and medical students, to assess the prevalance of temporomandibular disorders by using a validated questionnare. later 10 ml of salival will be collected in 20 students who are diagnosed with Tmd and 20 healthy students without TMD, to asses the salivary cortisol levels.
No publication done till date on this topic. |