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
|
|
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. |