An observational study in Tinnitus, Temporomandibular Joint Disorders and Somatosensory Tinnitus, sponsored by Kutahya Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Kutahya Health Sciences University · Observational
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.
Background and Rationale:
Tinnitus is defined as the conscious perception of sound in the absence of an external acoustic source. Subjective tinnitus, the most common form, is often associated with neuroplastic changes in the central auditory pathways. A specific subtype, Somatosensory Tinnitus (ST), occurs when afferent somatosensory input from the upper cervical or temporomandibular region modulates tinnitus perception. This interaction is mediated through neural connections between the Dorsal Cochlear Nucleus (DCN) and somatosensory nuclei in the brainstem. Clinical observations indicate a high prevalence of Temporomandibular Disorders (TMD) among tinnitus patients, suggesting a biological link where TMD symptoms (pain, restricted movement, and muscle activity) influence the spontaneous neuronal firing rates in the auditory centers.
Study Objectives:
While evidence points to a strong interaction between TMJ somatosensory input and tinnitus, the roles of auditory function and TMJ bone morphology-specifically condylar changes and the Petrotympanic Fissure (PTF)-remain under-investigated. This study aims to provide a comprehensive multidisciplinary analysis by evaluating the auditory system through audiological tests and examining morphological changes in TMJ bone tissues using Cone Beam Computed Tomography (CBCT).
Methodology:
Patients presenting to the Otorhinolaryngology (ENT) clinic with otological complaints (tinnitus and ear pain) and suspected of having TMD will be referred to the Dentomaxillofacial Radiology clinic.
Clinical Evaluation: A standardized anamnesis will be recorded, including demographics, systemic health, and bruxism history. Physical examination will involve bilateral palpation of the TMJ and masticatory muscles, alongside measurements of maximum mouth opening, lateral excursions, and protrusive movements.
Radiographic Protocol: CBCT images will be acquired using the Instrumentarium OP300 Dental unit (89 kvP, 4-12 mA) with patients in an upright position and maximum intercuspation.
Image Analysis: Using OnDemand 3D Dental software, a radiologist with 10 years of experience will evaluate:
Condylar Morphology: Classified as convex, round, angled, or flat.
Osteoarthritic Changes: Presence of flattening, resorption, subchondral cysts, sclerosis, and osteophytes.
Glenoid Fossa \& PTF: Fossa depth will be measured. The PTF morphology will be categorized according to the Sato et al. classification:
Type 1 (Open): Fissure clearly visible.
Type 2 (Partially Open): Fissure partially closed.
Type 3 (Closed): Fissure completely ossified.
Hypothesis:
The investigators hypothesize that normalizing afferent input from the temporomandibular region through multidisciplinary TMD management may alleviate tinnitus symptoms, and that specific morphological variations in the TMJ/PTF complex are correlated with the severity of subjective tinnitus.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 57 observational studies indexed under Tinnitus.
Browse Tinnitus studies →Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who applied to the Otorhinolaryngology clinic with tinnitus complaints and were subsequently diagnosed with TMD in the Dentomaxillofacial Radiology clinic
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with Temporomandibular Disorders (TMD) based on clinical examination and history, who also report co-existing subjective tinnitus. This group will be evaluated for both TMJ morphological changes (via CBCT) and audiological status.
Diagnostic Test: Cone Beam Computed Tomography (CBCT) · Diagnostic Test: Audiological Assessment · Other: Clinical TMJ Examination
Patients diagnosed with Temporomandibular Disorders (TMD) but who do not experience any form of tinnitus (subjective or objective). This group serves as a control to compare the specific TMJ morphological variations and audiological findings associated with the presence of tinnitus.
Diagnostic Test: Cone Beam Computed Tomography (CBCT) · Diagnostic Test: Audiological Assessment · Other: Clinical TMJ Examination
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.
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.
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).
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).
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.
Pure Tone Thresholds
Evaluation of hearing levels across standard frequencies (250 Hz to 8000 Hz) measured in decibels (dB).
Time frame: Baseline
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.
Plan to share: No — The individual participant data will not be available to other researchers to maintain patient confidentiality and as per the ethics committee approval.
Start is estimated for Apr 2026; primary completion for May 2026, 1 month later.
Of 20 observational studies under Tinnitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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