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Completed

NCT Number: NCT07298512

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

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.

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Key information

Age range

14 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

About this study

This study will prospectively evaluate temporomandibular joint (TMJ) disc perforation using magnetic resonance imaging (MRI) in a diverse adult population. The investigation will focus on identifying the prevalence of disc perforation and examining its relationship with key TMJ structural and functional parameters. Specifically, the study will assess internal disc derangements, variations in disc morphology, condylar bone marrow signal characteristics, and the presence of joint effusion. In addition, demographic and clinical factors-including age, sex, dental status, and pain severity-will be analyzed to determine their potential association with disc perforation.

MRI-based assessments will be performed using standardized imaging protocols, and all findings will be systematically recorded and evaluated. By integrating radiologic and clinical data, the study aims to improve the understanding of factors contributing to TMJ disc perforation and to support future diagnostic and therapeutic strategies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Presence of TMJ Disc Perforation

    Time frame: At MRI assessment (baseline, single time point)

    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

Secondary outcomes

  1. Disc Configuration Distribution

    Time frame: At MRI assessment (baseline)

    Categorical outcome describing temporomandibular joint disc morphology classified as biconcave, concave, flattened, folded, amorphous, or perforated, determined from closed-mouth MRI images evaluated by an experienced radiologist/oral and maxillofacial surgeon.

    Unit of Measure: Percentage of joints in each disc morphology category

  2. Disc Position (Closed/Open-mouth)

    Time frame: At MRI assessment (baseline)

    Categorical: Normal, Anterior Disc Displacement with Reduction (ADDWR), Anterior Disc Displacement without Reduction (ADDWoR). Determined by posterior band position relative to condyle on closed- and open-mouth images.

    Unit of Measure: Percentage of joints in each internal disc status category

  3. Condylar Bone Marrow Signal Pattern

    Time frame: At MRI assessment (baseline)

    Categorical: Normal, Edema, Sclerosis, Combined Edema and Sclerosis. Proportion of joints with each signal pattern on PDWI and T2WI. Unit of Measure:

    Percentage of joints in each bone marrow signal pattern category

  4. Joint Effusion Grade

    Time frame: At MRI assessment (baseline)

    Ordinal: Grade 0-3 on T2WI (Grade 0 = no effusion; Grade 1 = dot/linear; Grade 2 = bands; Grade 3 = accumulation). Distribution of effusion grades. Unit of Measure: Percentage of joints in each effusion grade

  5. Pain Severity (VAS per TMJ)

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

    Continuous outcome describing temporomandibular joint pain intensity, measured using the Visual Analogue Scale (VAS; 0-10) as reported by patients and recorded by an oral and maxillofacial surgeon.

    Unit of Measure: Mean VAS pain score per joint (0-10)

  6. Dental Status

    Time frame: At clinical assessment (baseline): retrospective clinical data

    Discrete outcome describing the number of missing permanent teeth, with individual tooth numbers recorded according to the dental charting system.

    Unit of Measure: Number of missing teeth per patient

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Acronym: TMJ Disc

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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