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Clinical Trials/CTRI/2025/07/090719
CTRI/2025/07/090719
Recruiting
Not Applicable

Morphometric evaluation of temporomandibular joint using cone-beam computed tomography and association of clinical dysfunction index in patients with temporomandibular disorders

Dr Shruthi Hegde1 site in 1 country276 target enrollmentStarted: July 28, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Dr Shruthi Hegde
Enrollment
276
Locations
1
Primary Endpoint
To compare and evaluate difference in the morphology and morphometric features of the temporomandibular joint in patients with and without temporomandibular disorders

Overview

Brief Summary

Present study will be conducted to evaluate the morphometric parameters of the patients with and without TMD and to compare the morphometric features with the clinical dysfunction index.

Research Question

Do morphometric features of TMJ differ in patients with TMD and without TMD and do

morphometric features have an association with the clinical severity of TMD?

Methodology

A standard protocol will be followed for the diagnosis of the new patients reporting to the department. Patients will be explained in detail about the study, and informed consent will be obtained from the patients willing to participate. The study will be comprised of a total of 276 patients. The control group (Group I) includes 138 patients without TMD and the study group (Group II) includes 138 patients with TMD. Selective sampling method will be used to ensure similar age and sex distribution in the control group as the study group in order to avoid any arbitrary effect on study results. Study group will be further categorized into 3 subgroups according to the Research Diagnostic Criteria. Patient demographic details, history and clinical signs and symptoms recording will be carried out in data collection forms. The patients will be evaluated according to clinical dysfunction index. Depending on the total score obtained, patients will be classified as having a clinical Di between 0 and 4. CBCT analysis will be carried out for 552 joints (276 right side and 276 left side joints of 276 patients). The morphologic features and morphometric parameters such as mandibular condyle shape, glenoid fossa shape, condylar bony changes, condylar height, condylar width, anterior joint space, posterior joint space, superior joint space, glenoid fossa roof thickness, glenoid fossa width, glenoid fossa depth  will be evaluated  and analysed in the study.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Inclusion Criteria for Study Group 1.Patients reporting with complaint of pain in the TMJ region or muscles of mastication and diagnosed with Temporomandibular joint disorders(TMD) according to the Research Diagnostic Criteria (RDC/TMD).
  • 2.Patients who are willing to participate in the study.
  • Patients in the age group of 18 to 60 years Inclusion criteria for control group 1.Patients without Temporomandibular joint disorders (Helkimo clinical index =0) and require Cone beam computed tomography(CBCT) for the diagnosis and treatment planning 2.Patients who are willing to participate in the study 3.Patients in the age group of 18 to 60 years.

Exclusion Criteria

  • Exclusion Criteria for Study Group 1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces
  • Pregnancy
  • Patients with CBCT images having inadequate clarity or resolution Exclusion criteria for control group 1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces 2.Patients with history of systemic arthritis 3.Images with inadequate field of view (FOV) 4.Patients with CBCT images having inadequate clarity or resolution 5.Presence of degenerative changes in the CBCT images.

Outcomes

Primary Outcomes

To compare and evaluate difference in the morphology and morphometric features of the temporomandibular joint in patients with and without temporomandibular disorders

Time Frame: at baseline

Secondary Outcomes

  • To compare & evaluate the clinical, radiographic & morphometric features with types of temporomandibular disorders(at baseline)

Investigators

Sponsor
Dr Shruthi Hegde
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shruthi Hegde

A B Shetty Memorial Institute of Dental Sciences affiliated to Nitte (Deemed to be University)

Study Sites (1)

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