| CTRI Number |
CTRI/2025/08/092249 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
effect of Joint near your ear on foot posture |
|
Scientific Title of Study
|
EVALUATION OF THE EFFECT OF TEMPOROMANDIBULAR JOINT
DISORDERS ON MEDIAL LONGITUDINAL ARCH OF THE FOOT; A CROSS
SECTIONAL 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 |
Anusha I Katageri |
| Designation |
Post graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College
Mangalore
Mangalore 575018
Uttara Kannada
KARNATAKA
575018
India |
| Phone |
7795927374 |
| Fax |
|
| Email |
anushakatageri30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanath Kumar Shetty |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College
Mangalore
Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7795927374 |
| Fax |
|
| Email |
sanathshetty71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha I Katageri |
| Designation |
Post graduate |
| Affiliation |
Yenepoya Dental College |
| Address |
Yenepoya Dental College
Mangalore
Mangalore 575018
KARNATAKA
575018
India |
| Phone |
7795927374 |
| Fax |
|
| Email |
anushakatageri30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics
Yenepoya Dental College
Deralakatte
Mangalore 575018 |
|
|
Primary Sponsor
|
| Name |
Anusha I Katageri |
| Address |
Department of Prosthodontics
Yenepoya Dental College
Mangalore |
| Type of Sponsor |
Other [self funded] |
|
|
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 Anusha |
Yenepoya Dental college |
Department of Prosthodontics,Room no 1,Yenepoya Dental College,Deralakatte Mangalore 575018
Uttara Kannada
KARNATAKA |
7795927374
anushakatageri30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with and without presence signs and symptomsof temporomandibular joint disorders |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with and without the presence of signs and symptoms of
Temporomandibular joint disorders. |
|
| ExclusionCriteria |
| Details |
History of facial and mandibular trauma
History of orthognathic surgery
Systemic illness of rheumatic origin
Neurologic or muscular disorders
Psychosomatic and psychiatric diseases
Physical and mental disability
Participants who have undergone physiotherapy and speech therapy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study helps to assess the effect of temporomandibular joint disorders on
foot posture. If the correlation is established, the knowledge gained from this study can
be used to promote an interdisciplinary approach in diagnosing and treating patients
suffering from TMDs or postural disorders more efficiently. |
As it is a cross sectional study ,out come is known in 1st visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study helps to assess the effect of temporomandibular joint disorders on
foot posture. If the correlation is established, the knowledge gained from this study can
be used to promote an interdisciplinary approach in diagnosing & treating patients
suffering from TMDs or postural disorders more efficiently. |
The parameter is assessed on the same day of examination.No follow up period |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
25/08/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study aim is to evaluate the effect of TMDs on the medial longitudinal arch of the
foot. If the correlation is found, it will be useful data for early diagnosis and treatment
planning for TMDs and body gait changes. It is a cross-sectional study with 25
individuals in the test group (with TMDs) and 25 in the control group (without TMDs).
Individuals within the age group of 18 to 40 will be included in the study. Exclusion
criteria will include individuals with neuromuscular, rheumatoid conditions. The study
will begin only after approval from the institutional ethical committee. Participants will
be informed about the details of the study, and the participant information sheet informed
consent form will be signed by them before the study. The study will be carried out in 4
steps, evaluation of the TMD symptoms will be done using a questionnaire. TMD signs
will be clinically evaluated based on DC/TMD criteria (2014). If any symptom listed, is
confirmed by clinical evaluation, the participant will be included in the test group. Flat
foot will be determined by measuring the medial longitudinal arch angle by 2
investigators. Goniometer will be used to measure the angle. The values will be noted in
the data collection sheet. Individual T-tests will be done for statistical analysis. Thus, the
data obtained will be correlated to TMD signs and symptoms. |