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CTRI Number  CTRI/2022/01/039247 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 11/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of click patterns in the jaw and its association with lifestyle factors 
Scientific Title of Study   Prevalence and association of Temporomandibular Joint click patterns with lifestyle factors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debolina Ghosh 
Designation  Intern 
Affiliation  Manipal College of Dental Sciences Manipal 
Address  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  8660263235  
Fax  08202922210  
Email  debolina.ghosh@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vineetha R 
Designation  Professor and Head of Department of Oral Medicine and Radiology. 
Affiliation  Manipal College of Dental Sciences Manipal 
Address  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9964896254  
Fax  08202922210  
Email  vineetha.manu@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Medhini Madi 
Designation  Assistant Professor 
Affiliation  Manipal College of Dental Sciences Manipal 
Address  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986009015  
Fax  08202922210  
Email  medhini.madi@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Dental Sciences, Manipal 
 
Primary Sponsor  
Name  Debolina Ghosh 
Address  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Aishwarya Tiwari  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal 
Dr Kalyana Chakravarthy Pentapati  Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal 
Dr Medhini Madi  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal 
Dr Vineetha R  Department of Oral Medicine and Radiology Manipal College of Dental Sciences Manipal 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Medhini Madi  Manipal College of Dental Sciences, Manipal  Room No-1, Department of Oral Medicine and Radiology
Udupi
KARNATAKA 
9986009015
08202922210
medhini.madi@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M278||Other specified diseases of jaws,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of age 18 and above years and those who are willing to participate will be included in the study 
 
ExclusionCriteria 
Details  Patients with history of craniofacial injury, systemic diseases affecting bones and joints, psychiatric disorders and patients undergoing orthodontic treatment will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of TMJ click and association of TMJ click with lifestyle factors  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Associated factors such as headache, irregular sleep cycle, fatigue, stress seen in patients with TMJ click.  4 weeks 
 
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)   10/01/2022 
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="2"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Temporomandibular disorders (TMD) comprises of a group of conditions involving the TMJ, the muscles of mastication and the associated structures. They constitute musculoskeletal and neuromuscular conditions. TMJ sounds are one of the common TMJ complaints, the patients report to the dentist. These sounds may be associated with pain and / or limitation of mouth opening or may present with no symptoms. Many of these click sounds are soft and not heard by another person, but it can be felt during the jaw movements.  However, this can be annoying and patients may feel uncomfortable and anxious due to the sounds produced.

Pathophysiologically, the clicks occur due to anterior disc displacement of the articular disc. When the displaced articular disc tries to move to its original position, the friction between the bony components produces a snapping sound which is heard as a click or pop. The abnormal morphologic changes of the articulating components as well as perforations and adhesions in the TMJ compartment can result in TMJ clicks. Depending on the clinical presentation and pattern of the click, its severity is assessed and the decisions on treatment options are taken. Majority of the clicks are innocuous and self-limiting and do not need any active intervention.  However, in few instances, the clicks can progress to disc displacement without reduction and lead to restricted mouth opening and impaired quality of life.

The TMJ disorders are closely linked with various lifestyle factors like sleep pattern, chewing pattern (unilateral / Bilateral) parafunctional habits etc. Even though various studies are available in the literature regarding the TMJ disorders, studies on the prevalence and pattern of clicks are sparse. Being a common and annoying complaint, it is very important to understand the predisposing factors and the pattern of TMJ so that patients can be instructed to avoid such habits to prevent the progressiveTMDs.1 Hence, the present study was aimed to evaluate the various types of TMJ clicking sounds and their association with lifestyle factors.  

 
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