NCT07460193

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

February 20, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

TinnitusTemporomandibular Joint DisordersCone-Beam Computed TomographyAudiometry

Outcome Measures

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.

    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

    Baseline.

  • Pure Tone Thresholds

    Baseline

  • Maximum Pain-Free Mouth Opening

    Baseline.

Study Arms (2)

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.

Diagnostic Test: Cone Beam Computed Tomography (CBCT)Diagnostic Test: Audiological AssessmentOther: 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.

Diagnostic Test: Cone Beam Computed Tomography (CBCT)Diagnostic Test: Audiological AssessmentOther: Clinical TMJ Examination

Interventions

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.

TMD with Tinnitus (Case Group)TMD without Tinnitus (Control Group)

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.

TMD with Tinnitus (Case Group)TMD without Tinnitus (Control 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).

TMD with Tinnitus (Case Group)TMD without Tinnitus (Control Group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

TinnitusTemporomandibular Joint DisordersOsteoarthritis

Interventions

Cone-Beam Computed Tomography

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesArthritisRheumatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Central Study Contacts

EDA İZGİ, Asst. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 20, 2026

First Posted

March 10, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion

July 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The individual participant data will not be available to other researchers to maintain patient confidentiality and as per the ethics committee approval.

Locations