Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 5:11 PM
Study NCT ID:
NCT07460193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054893', 'term': 'Cone-Beam Computed Tomography'}], 'ancestors': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Petrotympanic Fissure (PTF) Morphological Types', 'timeFrame': 'Baseline (at the time of the single CBCT scan during the initial clinical visit).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Presence of Osteoarthritic Changes in the Mandibular Condyle', 'timeFrame': 'Baseline.', 'description': '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".'}, {'measure': 'Pure Tone Thresholds', 'timeFrame': 'Baseline', 'description': 'Evaluation of hearing levels across standard frequencies (250 Hz to 8000 Hz) measured in decibels (dB).'}, {'measure': 'Maximum Pain-Free Mouth Opening', 'timeFrame': 'Baseline.', 'description': 'Measurement of the distance between the incisal edges of the upper and lower central incisors during maximum mouth opening, recorded in millimeters (mm).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tinnitus', 'Temporomandibular Joint Disorders', 'Cone-Beam Computed Tomography', 'Audiometry'], 'conditions': ['Tinnitus', 'Temporomandibular Joint Disorders', 'Somatosensory Tinnitus', 'Osteoarthritis, Temporomandibular Joint']}, 'referencesModule': {'references': [{'pmid': '26279489', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24286640', 'type': 'RESULT', 'citation': 'Buergers 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.'}, {'pmid': '18288438', 'type': 'RESULT', 'citation': 'Sato 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.', 'detailedDescription': 'Background and Rationale:\n\nTinnitus 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.\n\nStudy Objectives:\n\nWhile 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).\n\nMethodology:\n\nPatients 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.\n\nClinical 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.\n\nRadiographic 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.\n\nImage Analysis: Using OnDemand 3D Dental software, a radiologist with 10 years of experience will evaluate:\n\nCondylar Morphology: Classified as convex, round, angled, or flat.\n\nOsteoarthritic Changes: Presence of flattening, resorption, subchondral cysts, sclerosis, and osteophytes.\n\nGlenoid Fossa \\& PTF: Fossa depth will be measured. The PTF morphology will be categorized according to the Sato et al. classification:\n\nType 1 (Open): Fissure clearly visible.\n\nType 2 (Partially Open): Fissure partially closed.\n\nType 3 (Closed): Fissure completely ossified.\n\nHypothesis:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who applied to the Otorhinolaryngology clinic with tinnitus complaints and were subsequently diagnosed with TMD in the Dentomaxillofacial Radiology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* Patients presenting with otological symptoms such as tinnitus and ear pain.\n* Patients diagnosed with Temporomandibular Disorders (TMD) based on clinical and radiographic examination.\n* Patients who have been referred for CBCT imaging as part of their routine diagnostic process for TMD.\n* Willingness to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of objective tinnitus (e.g., vascular or muscular origin).\n* History of chronic otitis media or other middle ear pathologies that could cause hearing loss or tinnitus.\n* Previous history of temporomandibular joint surgery or major maxillofacial trauma.\n* Presence of systemic metabolic bone diseases or inflammatory rheumatic diseases (e.g., Rheumatoid Arthritis).\n* History of malignancy in the head and neck region.\n* Pregnancy (due to CBCT imaging contraindication).\n* Neurological or psychological disorders that would prevent cooperation during clinical and audiological examinations.'}, 'identificationModule': {'nctId': 'NCT07460193', 'briefTitle': 'CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Investigation of the Interaction Between Temporomandibular Joint and Tinnitus Using CBCT and Audiological Methods: A Prospective Cross-Sectional Study', 'orgStudyIdInfo': {'id': '2026/02-45'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TMD with Tinnitus (Case Group)', 'description': '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.', 'interventionNames': ['Diagnostic Test: Cone Beam Computed Tomography (CBCT)', 'Diagnostic Test: Audiological Assessment', 'Other: Clinical TMJ Examination']}, {'label': 'TMD without Tinnitus (Control Group)', 'description': '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.', 'interventionNames': ['Diagnostic Test: Cone Beam Computed Tomography (CBCT)', 'Diagnostic Test: Audiological Assessment', 'Other: Clinical TMJ Examination']}], 'interventions': [{'name': 'Cone Beam Computed Tomography (CBCT)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['TMD with Tinnitus (Case Group)', 'TMD without Tinnitus (Control Group)']}, {'name': 'Audiological Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['TMD with Tinnitus (Case Group)', 'TMD without Tinnitus (Control Group)']}, {'name': 'Clinical TMJ Examination', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['TMD with Tinnitus (Case Group)', 'TMD without Tinnitus (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43020', 'city': 'Kütahya', 'state': 'Kütahya', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EDA İZGİ, Asst. Prof.', 'role': 'CONTACT', 'email': 'eda.izgi@ksbu.edu.tr', 'phone': '+905543578814'}, {'name': 'TURAN CANMURAT İZGİ, Asst. Prof.', 'role': 'CONTACT', 'email': 'canmuratizgi@gmail.com', 'phone': '+905065076806'}, {'name': 'Eda İzgi, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Melike Yurttaş, Assoc. Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Turan Canmurat İzgi, Asst. Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emine Altun, Res. Asst.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kütahya Health Sciences University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'centralContacts': [{'name': 'EDA İZGİ, Asst. Prof.', 'role': 'CONTACT', 'email': 'eda.ucbas@ksbu.edu.tr', 'phone': '+905543578814'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data will not be available to other researchers to maintain patient confidentiality and as per the ethics committee approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'EDA İZGİ', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}