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CTRI Number  CTRI/2025/06/089789 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of jaw joint on body posture 
Scientific Title of Study   Evaluation of effect of temporomadibular joint disorders on body posture;A crosssectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha I Katageri 
Designation  Post graduate student 
Affiliation  Yenepoya Dental College 
Address  Yenepoya Dental College,department of prosthodontics,basement floor,Near KS Hegde Medical College Deralakatte Mangalore Department of Prosthodontics
Yenepoya Dental College,Near KS Hegde Medical College Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
580001
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  Department Of Prosthodontics
Yenepoya Dental College,Near KS Hegde Medical College Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India 
Phone  7795927374  
Fax    
Email  sanathshetty71@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anusha I Katageri 
Designation  Post graduate student 
Affiliation  Yenepoya Dental College 
Address  Yenepoya Dental College,Near KS Hegde Medical College Department of prosthodontics Deralakatte Mangalore
Yenepoya Dental College,Near KS Hegde Medical College Deralakatte Mangalore
Dakshina Kannada
KARNATAKA
580001
India 
Phone  7795927374  
Fax    
Email  anushakatageri30@gmail.com  
 
Source of Monetary or Material Support  
Yenepoya Dental College Deralakatte Mangalore 575018 
 
Primary Sponsor  
Name  Anusha I Katageri 
Address  Department of Prosthodontics Yenepoya Dental College Mangalore 575018 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnusha  Yenepoya Dental College  Yenepoya Dental College Department of prosthodontics ,basement floor,Near KS Hegde Medical College Deralakatte Mangalore
Dakshina 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  WITH AND WITHOUT 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  WITH AND WITHOUT 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   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the mean head-shoulder angle with a 95% level of confidence, and 12% relative precision 41 subjects must be included in each group. The total sample size required for this study is 41in each group.  at base line 
 
Secondary Outcome  
Outcome  TimePoints 
evaluation of symmetry of head shoulder angle in participants with & without Temporomandibular joint disorders, determining correlation between craniovertebral angle & TMDs.  at base line 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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)   05/06/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [14anusha.katageri@gmail.com].

  6. For how long will this data be available start date provided 23-12-2025 and end date provided 23-11-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study’s aim is to evaluate the effect of TMDs on body posture. If the correlation is found, it will be useful data for early diagnosis and treatment planning for TMDs and body postural changes.

         It is a cross-sectional study with 41 individuals in the test group (with TMDs) and 41 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, participant information sheet and informed consent form will be signed by them prior to 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.

          Body posture will be evaluated by measuring head shoulder angle and craniovertebral angle. The photographic analysis will be done for evaluating the symmetry of the head-shoulder angle. A standardized protocol will be followed to click the photographs, angles will be analyzed by GIMP computer software. The craniovertebral angle will be measured using a goniometer.

          The values will be noted in the data collection sheet. Individual T tests and Pearson’s correlation will be done for statistical analysis. Thus, the data obtained will be correlated to TMD signs and symptoms.

 
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