TinnitusNCT07460193
CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship
An observational study of Tinnitus and Temporomandibular Joint Disorders, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Temporomandibular Joint Disorders, Somatosensory Tinnitus
- What is being tested?
- Cone Beam Computed Tomography (CBCT), Audiological Assessment and Clinical TMJ Examination
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who applied to the Otorhinolaryngology clinic with tinnitus complaints and were subsequently diagnosed with TMD in the Dentomaxillofacial Radiology clinic
Who may be able to join
- 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.
- Willingness to provide written informed consent to participate in the study.
Who cannot join
- 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).
- History of malignancy in the head and neck region.
- Pregnancy (due to CBCT imaging contraindication).
- Neurological or psychological disorders that would prevent cooperation during clinical and audiological examinations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Kütahya, Kütahya, 43020
EDA İZGİ, Asst. Prof., +905543578814, eda.izgi@ksbu.edu.tr
TURAN CANMURAT İZGİ, Asst. Prof., +905065076806, canmuratizgi@gmail.com
About this study
Official title: Investigation of the Interaction Between Temporomandibular Joint and Tinnitus Using CBCT and Audiological Methods: A Prospective Cross-Sectional Study
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.
Read the detailed description
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.
- Conditions
- Tinnitus, Temporomandibular Joint Disorders, Somatosensory Tinnitus, Osteoarthritis, Temporomandibular Joint
- Being tested
- Cone Beam Computed Tomography (CBCT), Audiological Assessment, Clinical TMJ Examination
- Keywords
- Tinnitus, Temporomandibular Joint Disorders, Cone-Beam Computed Tomography, Audiometry
- Medical subject headings
- Tinnitus, Temporomandibular Joint Disorders, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AssessmentDiagnostic 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 ExaminationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| TMD with Tinnitus (Case Group) | 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. Receives: Diagnostic Test: Cone Beam Computed Tomography (CBCT); Diagnostic Test: Audiological Assessment; Other: Clinical TMJ Examination | |
| TMD without Tinnitus (Control Group) | 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. Receives: Diagnostic Test: Cone Beam Computed Tomography (CBCT); Diagnostic Test: Audiological Assessment; Other: Clinical TMJ Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at the time of the single CBCT scan during the initial clinical visit).
Secondary outcomes (3)
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".
Measured: Baseline.
Pure Tone Thresholds
Evaluation of hearing levels across standard frequencies (250 Hz to 8000 Hz) measured in decibels (dB).
Measured: 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).
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA İZGİ, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460193
- Sponsor's protocol ID
- 2026/02-45
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be available to other researchers to maintain patient confidentiality and as per the ethics committee approval.
Publications
Cakur B, Yasa Y. Correlation Between Tinnitus and Petrotympanic Fissure Status Among Patients With Temporomandibular Joint Dysfunction. J Oral Maxillofac Surg. 2016 Jan;74(1):47-52. doi: 10.1016/j.joms.2015.07.020. Epub 2015 Jul 31.
PubMed 26279489Buergers R, Kleinjung T, Behr M, Vielsmeier V. Is there a link between tinnitus and temporomandibular disorders? J Prosthet Dent. 2014 Mar;111(3):222-7. doi: 10.1016/j.prosdent.2013.10.001. Epub 2013 Nov 25.
PubMed 24286640Sato I, Arai H, Asaumi R, Imura K, Kawai T, Yosue T. Classifications of tunnel-like structure of human petrotympanic fissure by cone beam CT. Surg Radiol Anat. 2008 Jun;30(4):323-6. doi: 10.1007/s00276-008-0327-4. Epub 2008 Feb 21.
PubMed 18288438
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Interaction Between Temporomandibular Joint and Tinnitus Using CBCT and Audiological Methods: A Prospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07460193
- Acronym / sponsor ID
- 2026/02-45
- Conditions
- Tinnitus, Temporomandibular Joint Disorders, Somatosensory Tinnitus, Osteoarthritis, Temporomandibular Joint
- Keywords
- Tinnitus, Temporomandibular Joint Disorders, Cone-Beam Computed Tomography, Audiometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMD with Tinnitus (Case Group) | – | Diagnostic Test: Cone Beam Computed Tomography (CBCT), Diagnostic Test: Audiological Assessment, Other: Clinical TMJ ExaminationPatients 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. |
| TMD without Tinnitus (Control Group) | – | Diagnostic Test: Cone Beam Computed Tomography (CBCT), Diagnostic Test: Audiological Assessment, Other: Clinical TMJ ExaminationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to the Otorhinolaryngology clinic with tinnitus complaints and were subsequently diagnosed with TMD in the Dentomaxillofacial Radiology clinic
Key inclusion criteria (5 listed)
- 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.
- Willingness to provide written informed consent to participate in the study.
Key exclusion criteria (7 listed)
- 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).
- History of malignancy in the head and neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed Tomography (CBCT)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. | Diagnostic test | TMD with Tinnitus (Case Group), TMD without Tinnitus (Control Group) |
| Audiological AssessmentA 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. | Diagnostic test | TMD with Tinnitus (Case Group), TMD without Tinnitus (Control Group) |
| Clinical TMJ ExaminationSystematic 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). | Other | TMD with Tinnitus (Case Group), TMD without Tinnitus (Control Group) |
Primary outcome
Frequency of Petrotympanic Fissure (PTF) Morphological Types
Time frame: Baseline (at the time of the single CBCT scan during the initial clinical visit).
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.
3 secondary outcomes
Presence of Osteoarthritic Changes in the Mandibular Condyle
Time frame: Baseline.
Pure Tone Thresholds
Time frame: Baseline
Maximum Pain-Free Mouth Opening
Time frame: Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 26279489Cakur B, Yasa Y. Correlation Between Tinnitus and Petrotympanic Fissure Status Among Patients With Temporomandibular Joint Dysfunction. J Oral Maxillofac Surg. 2016 Jan;74(1):47-52. doi: 10.1016/j.joms.2015.07.020. Epub 2015 Jul 31.
- Results publication: PubMed 24286640Buergers R, Kleinjung T, Behr M, Vielsmeier V. Is there a link between tinnitus and temporomandibular disorders? J Prosthet Dent. 2014 Mar;111(3):222-7. doi: 10.1016/j.prosdent.2013.10.001. Epub 2013 Nov 25.
- Results publication: PubMed 18288438Sato I, Arai H, Asaumi R, Imura K, Kawai T, Yosue T. Classifications of tunnel-like structure of human petrotympanic fissure by cone beam CT. Surg Radiol Anat. 2008 Jun;30(4):323-6. doi: 10.1007/s00276-008-0327-4. Epub 2008 Feb 21.
- Individual participant dataSharing planned: No. The individual participant data will not be available to other researchers to maintain patient confidentiality and as per the ethics committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus and Temporomandibular Joint Disorders, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EDA İZGİ, Asst. Prof. (+905543578814, eda.ucbas@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Petrotympanic Fissure (PTF) Morphological Types (time frame: Baseline (at the time of the single CBCT scan during the initial clinical visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.