| CTRI Number |
CTRI/2018/10/016144 [Registered on: 24/10/2018] Trial Registered Prospectively |
| Last Modified On: |
23/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A STUDY TO EVALUATE THE TEMPOROMANDIBULAR JOINT PROBLEMS AMONG SOUTH INDIAN PROFFESIONAL STUDENTS AND FACTORS ASSOCIATED WITH IT |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE PREVALENCE OF TEMPOROMANDIBULAR DISORDERS IN SOUTH INDIAN PROFESSIONAL STUDENTS AND TO DETERMINE THE PSYCHOLOGICAL, FUNCTIONAL AND OCCLUSAL ASPECTS ASSOCIATED WITH IT. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONIA ALEX |
| Designation |
POST GRADUATE STUDENT IN ORTHODONTICS |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE ND HOSPITAL, HASSAN |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, HASSAN, KARNATAKA
573201
INDIA
Hassan
KARNATAKA
573201
India |
| Phone |
9495595226 |
| Fax |
|
| Email |
soniaalex2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR REJI ABRAHAM |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE ND HOSPITAL, HASSAN |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, HASSAN, KARNATAKA 573201
INDIA
Hassan
KARNATAKA
573201
India |
| Phone |
9947357788 |
| Fax |
|
| Email |
rejiabm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR REJI ABRAHAM |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE ND HOSPITAL, HASSAN |
| Address |
DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, HASSAN, KARNATAKA
573201
INDIA
Hassan
KARNATAKA
573201
India |
| Phone |
9947357788 |
| Fax |
|
| Email |
rejiabm@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
VIDYANAGAR,, HASSAN,KARNATAKA 573201 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR SONIA ALEX |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
ROOM NO: 7 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS.SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL VIDYANAGAR. HASSAN KARNATAKA 573201
Hassan
KARNATAKA |
9495595226
soniaalex2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TEMPOROMANDIBULAR DISORDERS |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
South Indian students persuing professional education in colleges around Hassan town.
|
|
| ExclusionCriteria |
| Details |
1. Subjects other than South Indians.
2. Subjects those who refuse to participate.
3. Subjects presently under orthodontic treatment.
4. Presence of any craniofacial anomalies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PREVALENCE OF TEMPOROMANDIBULAR DISORDERS |
01-11-2018 10 months |
|
|
Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="1400"
Sample Size from India="1400"
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)
|
01/11/2018 |
| 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 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
|
This epidemiological study will be taken up to
evaluate the prevalence of temporomandibular disorders in South Indian
professional students & also to assess the psychological, functional and
occlusal aspects associated with temporomandibular disorders. The clinical
data will be derived from a large numbers of patients, so that there can be a
better understanding about the various complex symptomatology of the
temporomandibular disorders. This may also provide data to frame the patient
need of care in particular and may indeed help in early diagnosis and can help
to apply prevention therapies among the vulnerable student population.
|