Clinico-radiological Correlation of MRI Findings in Patients With Temporomandibular Joint Disc Perforation

NCT07298512 | Completed

• 1 other identifier: 2025/48
• Study Type: observational
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the presence of TMJ disc perforation on MRI and investigate its associations with internal disc derangements, disc configuration, condylar bone marrow signal patterns, joint effusion, and demographic or clinical variables such as age, sex, dental status, and pain severity.

Conditions

Temporomandibular Joint Disc Displacement; Magnetic Resonance Imaging; Bone Marrow

Outcome Measures

Primary Outcomes (1)

• Presence of TMJ Disc Perforation

  Dichotomous outcome (Yes/No) indicating the presence of temporomandibular joint disc perforation, determined from closed- and open-mouth MRI images assessed by an experienced radiologist/oral and maxillofacial surgeon. Unit of Measure: Percentage of joints with MRI-confirmed disc perforation

  At MRI assessment (baseline, single time point)

Secondary Outcomes (6)

• Disc Configuration Distribution

  At MRI assessment (baseline)

• Disc Position (Closed/Open-mouth)

  At MRI assessment (baseline)

• Condylar Bone Marrow Signal Pattern

  At MRI assessment (baseline)

• Joint Effusion Grade

  At MRI assessment (baseline)

• Pain Severity (VAS per TMJ)

  At clinical assessment coincident with MRI (baseline): retrospective clinical data

Study Arms (2)

Group 1: Disc Perforation Group

Participants who demonstrate temporomandibular joint (TMJ) disc perforation on MRI. This cohort will be used to evaluate imaging characteristics and clinical parameters associated with perforation.

Group 2: Non-Perforation Group

Participants without MRI evidence of TMJ disc perforation.

Eligibility Criteria

• Age: 14 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of approximately 282 patients (200 females and 82 males) aged 14-79 years who have undergone TMJ MRI scans for clinical evaluation. Patients will be included if they have complete MRI images (open- and closed-mouth) and corresponding clinical records, including Visual Analogue Scale (VAS) pain scores and detailed dental status. Individuals with systemic disorders affecting bone metabolism, history of bone-altering medications, current orthodontic treatment, prior head or neck trauma or surgery, head or neck cystic or tumoral pathology, previous radiotherapy or chemotherapy, pregnancy, or presence of ferromagnetic objects in the head will be excluded. The population will be stratified into two cohorts based on the presence or absence of TMJ disc perforation as determined by MRI.

You may qualify if:

• Patients with available temporomandibular joint (TMJ) MRI scans (both open- and closed-mouth)
• Age ≥14 years
• Complete clinical records including Visual Analogue Scale (VAS) pain scores and dental status
• Willingness to participate in the study and provide informed consent (for prospective studies)

You may not qualify if:

• Presence of systemic disorders affecting bone metabolism, including rheumatoid arthritis, chronic systemic corticosteroid therapy, Paget's disease, hypo- or hyperparathyroidism, osteomalacia, or renal osteodystrophy
• History of medications that could alter bone architecture
• Current orthodontic treatment
• History of head and neck trauma or surgery
• Presence of head and neck cystic or tumoral pathology
• Prior radiotherapy or chemotherapy
• Pregnancy
• Presence of ferromagnetic objects in the head (contraindication to MRI)

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 23, 2025
• Study Start: November 1, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)