Temporomandibular Joint Disc DisplacementTMJ DiscNCT07298512
Clinico-radiological Correlation of MRI Findings in Patients With Temporomandibular Joint Disc Perforation
An observational study of Temporomandibular Joint Disc Displacement and Magnetic Resonance Imaging, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the presence of TMJ disc perforation on MRI and investigate its associations with internal disc derangements, disc configuration, condylar bone marrow signal patterns, joint effusion, and demographic or clinical variables such as age, sex, dental status, and pain severity. Read more about this study
- Who is it for?
- Ages 14 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, Magnetic Resonance Imaging, Bone Marrow
- How many people
- 282 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 3 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of approximately 282 patients (200 females and 82 males) aged 14-79 years who have undergone TMJ MRI scans for clinical evaluation. Patients will be included if they have complete MRI images (open- and closed-mouth) and corresponding clinical records, including Visual Analogue Scale (VAS) pain scores and detailed dental status. Individuals with systemic disorders affecting bone metabolism, history of bone-altering medications, current orthodontic treatment, prior head or neck trauma or surgery, head or neck cystic or tumoral pathology, previous radiotherapy or chemotherapy, pregnancy, or presence of ferromagnetic objects in the head will be excluded. The population will be stratified into two cohorts based on the presence or absence of TMJ disc perforation as determined by MRI.
Who may be able to join
- Patients with available temporomandibular joint (TMJ) MRI scans (both open- and closed-mouth)
- Age ≥14 years
- Complete clinical records including Visual Analogue Scale (VAS) pain scores and dental status
- Willingness to participate in the study and provide informed consent (for prospective studies)
Who cannot join
- Presence of systemic disorders affecting bone metabolism, including rheumatoid arthritis, chronic systemic corticosteroid therapy, Paget's disease, hypo- or hyperparathyroidism, osteomalacia, or renal osteodystrophy
- History of medications that could alter bone architecture
- Current orthodontic treatment
- History of head and neck trauma or surgery
- Presence of head and neck cystic or tumoral pathology
- Prior radiotherapy or chemotherapy
- Pregnancy
- Presence of ferromagnetic objects in the head (contraindication to MRI)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize
About this study
To evaluate the presence of TMJ disc perforation on MRI and investigate its associations with internal disc derangements, disc configuration, condylar bone marrow signal patterns, joint effusion, and demographic or clinical variables such as age, sex, dental status, and pain severity.
Read the detailed description
This study will prospectively evaluate temporomandibular joint (TMJ) disc perforation using magnetic resonance imaging (MRI) in a diverse adult population. The investigation will focus on identifying the prevalence of disc perforation and examining its relationship with key TMJ structural and functional parameters. Specifically, the study will assess internal disc derangements, variations in disc morphology, condylar bone marrow signal characteristics, and the presence of joint effusion. In addition, demographic and clinical factors-including age, sex, dental status, and pain severity-will be analyzed to determine their potential association with disc perforation.
MRI-based assessments will be performed using standardized imaging protocols, and all findings will be systematically recorded and evaluated. By integrating radiologic and clinical data, the study aims to improve the understanding of factors contributing to TMJ disc perforation and to support future diagnostic and therapeutic strategies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Disc Perforation Group | Participants who demonstrate temporomandibular joint (TMJ) disc perforation on MRI. This cohort will be used to evaluate imaging characteristics and clinical parameters associated with perforation. | |
| Group 2: Non-Perforation Group | Participants without MRI evidence of TMJ disc perforation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of TMJ Disc Perforation
Dichotomous outcome (Yes/No) indicating the presence of temporomandibular joint disc perforation, determined from closed- and open-mouth MRI images assessed by an experienced radiologist/oral and maxillofacial surgeon.
Unit of Measure: Percentage of joints with MRI-confirmed disc perforation
Measured: At MRI assessment (baseline, single time point)
Secondary outcomes (6)
Disc Configuration Distribution
Categorical outcome describing temporomandibular joint disc morphology classified as biconcave, concave, flattened, folded, amorphous, or perforated, determined from closed-mouth MRI images evaluated by an experienced radiologist/oral and maxillofacial surgeon.
Unit of Measure: Percentage of joints in each disc morphology category
Measured: At MRI assessment (baseline)
Disc Position (Closed/Open-mouth)
Categorical: Normal, Anterior Disc Displacement with Reduction (ADDWR), Anterior Disc Displacement without Reduction (ADDWoR). Determined by posterior band position relative to condyle on closed- and open-mouth images.
Unit of Measure: Percentage of joints in each internal disc status category
Measured: At MRI assessment (baseline)
Condylar Bone Marrow Signal Pattern
Categorical: Normal, Edema, Sclerosis, Combined Edema and Sclerosis. Proportion of joints with each signal pattern on PDWI and T2WI. Unit of Measure:
Percentage of joints in each bone marrow signal pattern category
Measured: At MRI assessment (baseline)
Joint Effusion Grade
Ordinal: Grade 0-3 on T2WI (Grade 0 = no effusion; Grade 1 = dot/linear; Grade 2 = bands; Grade 3 = accumulation). Distribution of effusion grades. Unit of Measure: Percentage of joints in each effusion grade
Measured: At MRI assessment (baseline)
Pain Severity (VAS per TMJ)
Continuous outcome describing temporomandibular joint pain intensity, measured using the Visual Analogue Scale (VAS; 0-10) as reported by patients and recorded by an oral and maxillofacial surgeon.
Unit of Measure: Mean VAS pain score per joint (0-10)
Measured: At clinical assessment coincident with MRI (baseline): retrospective clinical data
Dental Status
Discrete outcome describing the number of missing permanent teeth, with individual tooth numbers recorded according to the dental charting system.
Unit of Measure: Number of missing teeth per patient
Measured: At clinical assessment (baseline): retrospective clinical data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Nov 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298512
- Sponsor's protocol ID
- 2025/48
- Acronym
- TMJ Disc
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-radiological Correlation of MRI Findings in Patients With Temporomandibular Joint Disc Perforation
- ClinicalTrials.gov ID
- NCT07298512
- Acronym / sponsor ID
- TMJ Disc / 2025/48
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 23 Dec 2025 (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.
To evaluate the presence of TMJ disc perforation on MRI and investigate its associations with internal disc derangements, disc configuration, condylar bone marrow signal patterns, joint effusion, and demographic or clinical variables such as age, sex, dental status, and pain severity.
Detailed description
This study will prospectively evaluate temporomandibular joint (TMJ) disc perforation using magnetic resonance imaging (MRI) in a diverse adult population. The investigation will focus on identifying the prevalence of disc perforation and examining its relationship with key TMJ structural and functional parameters. Specifically, the study will assess internal disc derangements, variations in disc morphology, condylar bone marrow signal characteristics, and the presence of joint effusion. In addition, demographic and clinical factors-including age, sex, dental status, and pain severity-will be analyzed to determine their potential association with disc perforation.
MRI-based assessments will be performed using standardized imaging protocols, and all findings will be systematically recorded and evaluated. By integrating radiologic and clinical data, the study aims to improve the understanding of factors contributing to TMJ disc perforation and to support future diagnostic and therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Disc Perforation Group | – | –Participants who demonstrate temporomandibular joint (TMJ) disc perforation on MRI. This cohort will be used to evaluate imaging characteristics and clinical parameters associated with perforation. |
| Group 2: Non-Perforation Group | – | –Participants without MRI evidence of TMJ disc perforation. |
Who may qualify
- Ages
- 14 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of approximately 282 patients (200 females and 82 males) aged 14-79 years who have undergone TMJ MRI scans for clinical evaluation. Patients will be included if they have complete MRI images (open- and closed-mouth) and corresponding clinical records, including Visual Analogue Scale (VAS) pain scores and detailed dental status. Individuals with systemic disorders affecting bone metabolism, history of bone-altering medications, current orthodontic treatment, prior head or neck trauma or surgery, head or neck cystic or tumoral pathology, previous radiotherapy or chemotherapy, pregnancy, or presence of ferromagnetic objects in the head will be excluded. The population will be stratified into two cohorts based on the presence or absence of TMJ disc perforation as determined by MRI.
Key inclusion criteria (4 listed)
- Patients with available temporomandibular joint (TMJ) MRI scans (both open- and closed-mouth)
- Age ≥14 years
- Complete clinical records including Visual Analogue Scale (VAS) pain scores and dental status
- Willingness to participate in the study and provide informed consent (for prospective studies)
Key exclusion criteria (8 listed)
- Presence of systemic disorders affecting bone metabolism, including rheumatoid arthritis, chronic systemic corticosteroid therapy, Paget's disease, hypo- or hyperparathyroidism, osteomalacia, or renal osteodystrophy
- History of medications that could alter bone architecture
- Current orthodontic treatment
- History of head and neck trauma or surgery
- Presence of head and neck cystic or tumoral pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of TMJ Disc Perforation
Time frame: At MRI assessment (baseline, single time point)
Dichotomous outcome (Yes/No) indicating the presence of temporomandibular joint disc perforation, determined from closed- and open-mouth MRI images assessed by an experienced radiologist/oral and maxillofacial surgeon. Unit of Measure: Percentage of joints with MRI-confirmed disc perforation
6 secondary outcomes
Disc Configuration Distribution
Time frame: At MRI assessment (baseline)
Disc Position (Closed/Open-mouth)
Time frame: At MRI assessment (baseline)
Condylar Bone Marrow Signal Pattern
Time frame: At MRI assessment (baseline)
Joint Effusion Grade
Time frame: At MRI assessment (baseline)
Pain Severity (VAS per TMJ)
Time frame: At clinical assessment coincident with MRI (baseline): retrospective clinical data
Dental Status
Time frame: At clinical assessment (baseline): retrospective clinical data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Temporomandibular Joint Disc Displacement and Magnetic Resonance Imaging, run by Recep Tayyip Erdogan University Training and Research Hospital 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of TMJ Disc Perforation (time frame: At MRI assessment (baseline, single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.