CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKutahya Health Sciences University

About this trial

The aim of this study is to investigate the relationship between Temporomandibular Disorders (TMD) and subjective tinnitus at both morphological and functional levels. Current literature suggests that somatosensory inputs from the temporomandibular joint (TMJ) and masticatory muscles can modulate auditory pathways, a phenomenon known as Somatosensory Tinnitus. However, the specific role of TMJ bone morphology and critical neighboring structures, such as the Petrotympanic Fissure (PTF), in this interaction remains unclear.

In this clinical study, patients with tinnitus will undergo a comprehensive evaluation including Cone Beam Computed Tomography (CBCT) to quantitatively analyze condylar morphology and osteoarthritic changes. Additionally, audiological tests will be performed to assess the functional state of the auditory system. This multidisciplinary approach aims to clarify the biological link between TMD and tinnitus, potentially improving diagnostic protocols and highlighting the importance of TMJ stabilization in tinnitus management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years and older.

Patients presenting with otological symptoms such as tinnitus and ear pain.

Patients diagnosed with Temporomandibular Disorders (TMD) based on clinical and radiographic examination.

Patients who have been referred for CBCT imaging as part of their routine diagnostic process for TMD.

Disqualifiers

Presence of objective tinnitus (e.g., vascular or muscular origin).

History of chronic otitis media or other middle ear pathologies that could cause hearing loss or tinnitus.

Previous history of temporomandibular joint surgery or major maxillofacial trauma.

Presence of systemic metabolic bone diseases or inflammatory rheumatic diseases (e.g., Rheumatoid Arthritis).

Trial population

Patients who applied to the Otorhinolaryngology clinic with tinnitus complaints and were subsequently diagnosed with TMD in the Dentomaxillofacial Radiology clinic

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cone Beam Computed Tomography (CBCT)

    Diagnostic test

    High-resolution 3D imaging of the temporomandibular joint (TMJ) using the Instrumentarium OP300 Dental unit. The procedure involves evaluating condylar morphology, osteoarthritic changes (flattening, resorption, osteophytes), and the anatomical structure of the Petrotympanic Fissure (PTF) based on the Sato et al. classification.

  • Audiological Assessment

    Diagnostic test

    A comprehensive evaluation of the auditory system to determine hearing thresholds and the functional status of the ear. This includes pure tone audiometry and specific tests to characterize the frequency and intensity of tinnitus in the patient group.

  • Clinical TMJ Examination

    Other intervention

    Systematic physical examination of the masticatory muscles and the TMJ. This includes bilateral palpation for pain and tenderness, assessment of mandibular range of motion (maximal mouth opening, lateral and protrusive movements), and recording of joint sounds (clicking or crepitation).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: TMD with Tinnitus (Case Group)3 interventions
Group B: TMD without Tinnitus (Control Group)3 interventions

Trial outcomes

Primary outcomes

1

Frequency of Petrotympanic Fissure (PTF) Morphological Types

The morphology of the PTF will be categorized into three types according to the Sato et al. classification: Type 1 (Open), Type 2 (Partially Open), and Type 3 (Closed) using CBCT imaging.

Time frame
Baseline (at the time of the single CBCT scan during the initial clinical visit).

Secondary outcomes

1

Presence of Osteoarthritic Changes in the Mandibular Condyle

Evaluation of degenerative changes including flattening, resorption, subchondral cysts, generalized sclerosis, and osteophytes on CBCT images. Each change will be recorded as "present" or "absent".

Time frame
Baseline.
2

Pure Tone Thresholds

Evaluation of hearing levels across standard frequencies (250 Hz to 8000 Hz) measured in decibels (dB).

Time frame
Baseline
3

Maximum Pain-Free Mouth Opening

Measurement of the distance between the incisal edges of the upper and lower central incisors during maximum mouth opening, recorded in millimeters (mm).

Time frame
Baseline.

Other outcomes

Sponsors and contacts

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