Temporomandibular Disorder (TMD)TMJNCT07429435
Morphometric and Morphological Analysis of Cervical Vertebrae in Disc Displacement
An observational study of Temporomandibular Disorder (TMD) and Cervical Vertebrae, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Temporomandibular disorders (TMDs) are multifactorial clinical conditions affecting the masticatory muscles, the temporomandibular joint (TMJ), and the surrounding structures. The most common subtype is disc displacement, which is characterized by an abnormal position of the articular disc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder (TMD), Cervical Vertebrae, Disc Displacement
- What is being tested?
- cephalometric analysis
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 31 Jul 2026
- How long will I take part?
- 1 Week
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Temporomandibular disorder
Who may be able to join
- Presence of TMJ symptoms on at least one side, including pain, abnormal mandibular movements, or joint noises.
- Parafunctional habits such as bruxism or clenching.
- Patients with disc displacement of TMJ.
Who cannot join
- Presence of malformations affecting the craniofacial region.
- History of trauma of the maxillofacial region.
- History of cervical surgery or any procedure involving the cervical region.
- Patients with tumors, cysts, hypoplasia, or hyperplasia in the TMJ region.
- Any condition related to a congenital anomaly or syndrome.
- Presence of contraindications to magnetic resonance imaging.
- Pregnancy.
- Women in the breastfeeding period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Kütahya, Kütahya, 43100
About this study
Official title: Imaging-Based Morphometric and Morphological Analysis of Cervical Vertebrae in Patients With TMJ Disc Displacement
Temporomandibular disorders (TMDs) are multifactorial clinical conditions affecting the masticatory muscles, the temporomandibular joint (TMJ), and the surrounding structures. The most common subtype is disc displacement, which is characterized by an abnormal position of the articular disc. Magnetic resonance imaging (MRI) is considered the gold standard for the diagnosis of disc displacement because it provides excellent soft tissue contrast, allows direct visualization of the disc, and enables dynamic evaluation. The parallel nature of mandibular and head-neck movements reflects the functional relationship between the temporomandibular and cervical neuromuscular systems. In addition, various craniofacial skeletal anomalies have been reported to be associated with disorders of the cervical vertebrae. TMD restricts mandibular movements and causes pain in the surrounding muscles, which may lead to referred pain in the neck, shoulder, and cervical muscles, thereby affecting head posture. Head and neck postural abnormalities are closely associated with cervical pain and dysfunction related to TMD. This relationship is thought to be bidirectional and can be explained through biomechanical, neurological, and pathophysiological mechanisms. In particular, upper cervical vertebral dysfunctions and changes in head position may influence the severity of TMD symptoms. For this purpose, lateral cephalometric radiography is frequently used to evaluate the hyoid position and the cervical spine in relation to the TMJ. Upper cervical vertebral anomalies and craniofacial morphological characteristics can be analyzed using these images.
Read the detailed description
A comprehensive medical history was obtained from all participants, including demographic characteristics (age, sex), systemic medical conditions (musculoskeletal, cardiovascular, and psychological diseases, and regular medication use), pain-related parameters (character, duration, and severity), TMD-related comorbidities (neck pain, headache, sleep disorders, and other pain syndromes), presence of bruxism, duration of mobile phone use, and body position during phone use (sitting or lying).
The temporomandibular joint region, masticatory muscles (masseter and temporalis), and cervical muscles (trapezius and sternocleidomastoid) were evaluated by palpation. Clinical TMJ parameters included limitation of mouth opening, presence of pain during opening, and joint sounds.
Patients included in the study were selected from individuals presenting to the clinic with TMJ-related symptoms. Patients with TMD and accompanying neck symptoms were evaluated using lateral cephalometric radiography, while the position of the articular disc was assessed using magnetic resonance imaging (MRI). MRI is routinely used for imaging the articular disc and surrounding soft tissues in patients with TMD and is considered the gold standard for the diagnosis of disc displacement. MRI images were independently evaluated by two maxillofacial radiologists (Melike Yurttaş and Emine Kübra Ceylan Altun), and only patients diagnosed with disc displacement were included in the study.
Morphological and morphometric measurements of the C2, C3, and C4 vertebral bodies were performed on lateral cephalometric radiographs of the included patients. Morphological assessment included the presence of osteophyte formation and generalized sclerosis of the vertebrae.
Morphometric measurements included vertebral body dimensions, craniovertebral posture parameters (NSL/OPT and OPT/HOR angles), hyoid triangle height, and intervertebral disc height. Vertebral dimensions were evaluated by measuring anterior height as the distance between the superior and inferior borders of the anterior vertebral margin, and posterior height as the distance between the superior and inferior borders of the posterior margin. Additionally, the anteroposterior diameter of the C2, C3, and C4 vertebrae was measured as vertebral depth, and the anterior height-to-depth ratio was calculated.
Intervertebral disc height between adjacent vertebrae was assessed using the inferior-anterior corner of the upper vertebra and the superior-anterior corner of the lower vertebra as reference points. An angle bisector was drawn between these points, and the perpendicular distances from both corners to the bisector were summed to obtain the anterior disc height. This value was divided by the depth of the lower vertebra to generate a dimensionless ratio unaffected by magnification differences.
Craniovertebral posture was evaluated using the NSL/OPT and OPT/HOR angles. For the NSL/OPT angle, the landmarks Nasion (N), Sella (S), cv2tg (the posterosuperior tangent point of the odontoid process of C2), and cv2ip (the posteroinferior point of the C2 vertebral body) were identified, and the angle between the NSL and OPT lines was measured. The OPT/HOR angle was defined as the angle between the true horizontal plane and the line tangent to the posterior surface of the odontoid process.
Hyoid triangle height was determined using a triangle formed by the most anterosuperior point of the hyoid bone (H), the anteroinferior point of the third cervical vertebra (C3ia), and retrognathion (RGN). All cephalometric measurements were performed using AudaxCeph software.
Statistical analyses were conducted to investigate the relationship between the obtained measurements and the presence of disc displacement.
- Conditions
- Temporomandibular Disorder (TMD), Cervical Vertebrae, Disc Displacement, Dentistry, Cephalometric Analysis
- Being tested
- cephalometric analysis
- Keywords
- temporomandibular disorder, cervical vertebrae, disc displacement, dentistry, cephalometric analysis
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalometric analysisRadiation
cephalometric analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
morphologic analysis of cervical vertebrae
Morphological measurements of the C2, C3, and C4 vertebral bodies were performed on lateral cephalometric radiographs of the included patients. Morphological assessment included the presence of osteophyte formation and generalized sclerosis of the vertebrae. Osteophytes are marginal bony proliferations arising from the periosteal surface of the vertebral body endplates, typically developing at the anterior and lateral aspects as a reactive response to chronic mechanical stress and intervertebral disc degeneration. Radiologically, they appear as well-defined osseous outgrowths that may vary in size and orientation and can occasionally contribute to adjacent soft tissue or neural structure compression depending on their extent. Generalized sclerosis refers to a diffuse increase in bone density involving the vertebral bodies, characterized radiologically by homogeneous or heterogeneous areas of increased radiopacity on imaging studies.
Measured: Start date: April 1, 2026 - End date: June 1, 2026
vertebral dimension measurements and intervertebral disc height
Anterior and posterior vertebral heights were defined as the distances between the superior and inferior borders of the anterior and posterior margins of the vertebral body. Anteroposterior diameter of C2, C3, and C4 was measured as vertebral depth, and the anterior height/depth ratio was calculated to obtain a dimensionless value independent of radiographic magnification. Anterior intervertebral disc height was determined by summing the perpendicular distances from the inferoanterior corner of the upper vertebra and the superoanterior corner of the lower vertebra to the angle bisector constructed between these points. This value was divided by the depth of the lower vertebra to obtain a magnification-independent ratio.
Measured: Start date: April 1, 2026 - End date: June 1, 2026
Secondary outcomes (1)
cervical posture evaluation
NSL/OPT and OPT/HOR angles will be calculated. In determining the NSL/OPT angle, the following landmarks will be identified: Nasion (N), Sella (S), CV2tg (the superoposterior tangent point of the odontoid process of C2), and CV2ip (the inferoposterior point of the C2 vertebral body). The NSL (Nasion-Sella Line) is defined as the line connecting the geometric center of the sella turcica and the nasion (the most anterior point of the frontonasal suture). The OPT (Odontoid Process Tangent) is defined as the line tangent to the posterior surface of the odontoid process of the second cervical vertebra (C2) passing through CV2ip. The OPT/HOR angle will be calculated as the angle between the true horizontal plane and the line tangent to the posterior surface of the odontoid process. Hyoid triangle height will be determined using the triangle formed by the most superoanterior point of the hyoid bone (H), the inferoanterior point of the third cervical vertebra (C3ia), and retrognathion (RGN).
Measured: Start date: April 1, 2026 - End date: June 1, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start28 Feb 2026
- Primary completion30 Apr 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies 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
- 115 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429435
- Sponsor's protocol ID
- KSBUADCR01
- Other IDs
- KSBUADCR01
- Acronym
- TMJ
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-Based Morphometric and Morphological Analysis of Cervical Vertebrae in Patients With TMJ Disc Displacement
- ClinicalTrials.gov ID
- NCT07429435
- Acronym / sponsor ID
- TMJ / KSBUADCR01
- Conditions
- Temporomandibular Disorder (TMD), Cervical Vertebrae, Disc Displacement, Dentistry, Cephalometric Analysis
- Keywords
- temporomandibular disorder, cervical vertebrae, disc displacement, dentistry, cephalometric analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 24 Feb 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.
Temporomandibular disorders (TMDs) are multifactorial clinical conditions affecting the masticatory muscles, the temporomandibular joint (TMJ), and the surrounding structures. The most common subtype is disc displacement, which is characterized by an abnormal position of the articular disc. Magnetic resonance imaging (MRI) is considered the gold standard for the diagnosis of disc displacement because it provides excellent soft tissue contrast, allows direct visualization of the disc, and enables dynamic evaluation. The parallel nature of mandibular and head-neck movements reflects the functional relationship between the temporomandibular and cervical neuromuscular systems. In addition, various craniofacial skeletal anomalies have been reported to be associated with disorders of the cervical vertebrae. TMD restricts mandibular movements and causes pain in the surrounding muscles, which may lead to referred pain in the neck, shoulder, and cervical muscles, thereby affecting head posture. Head and neck postural abnormalities are closely associated with cervical pain and dysfunction related to TMD. This relationship is thought to be bidirectional and can be explained through biomechanical, neurological, and pathophysiological mechanisms. In particular, upper cervical vertebral dysfunctions and changes in head position may influence the severity of TMD symptoms. For this purpose, lateral cephalometric radiography is frequently used to evaluate the hyoid position and the cervical spine in relation to the TMJ. Upper cervical vertebral anomalies and craniofacial morphological characteristics can be analyzed using these images.
Detailed description
A comprehensive medical history was obtained from all participants, including demographic characteristics (age, sex), systemic medical conditions (musculoskeletal, cardiovascular, and psychological diseases, and regular medication use), pain-related parameters (character, duration, and severity), TMD-related comorbidities (neck pain, headache, sleep disorders, and other pain syndromes), presence of bruxism, duration of mobile phone use, and body position during phone use (sitting or lying).
The temporomandibular joint region, masticatory muscles (masseter and temporalis), and cervical muscles (trapezius and sternocleidomastoid) were evaluated by palpation. Clinical TMJ parameters included limitation of mouth opening, presence of pain during opening, and joint sounds.
Patients included in the study were selected from individuals presenting to the clinic with TMJ-related symptoms. Patients with TMD and accompanying neck symptoms were evaluated using lateral cephalometric radiography, while the position of the articular disc was assessed using magnetic resonance imaging (MRI). MRI is routinely used for imaging the articular disc and surrounding soft tissues in patients with TMD and is considered the gold standard for the diagnosis of disc displacement. MRI images were independently evaluated by two maxillofacial radiologists (Melike Yurttaş and Emine Kübra Ceylan Altun), and only patients diagnosed with disc displacement were included in the study.
Morphological and morphometric measurements of the C2, C3, and C4 vertebral bodies were performed on lateral cephalometric radiographs of the included patients. Morphological assessment included the presence of osteophyte formation and generalized sclerosis of the vertebrae.
Morphometric measurements included vertebral body dimensions, craniovertebral posture parameters (NSL/OPT and OPT/HOR angles), hyoid triangle height, and intervertebral disc height. Vertebral dimensions were evaluated by measuring anterior height as the distance between the superior and inferior borders of the anterior vertebral margin, and posterior height as the distance between the superior and inferior borders of the posterior margin. Additionally, the anteroposterior diameter of the C2, C3, and C4 vertebrae was measured as vertebral depth, and the anterior height-to-depth ratio was calculated.
Intervertebral disc height between adjacent vertebrae was assessed using the inferior-anterior corner of the upper vertebra and the superior-anterior corner of the lower vertebra as reference points. An angle bisector was drawn between these points, and the perpendicular distances from both corners to the bisector were summed to obtain the anterior disc height. This value was divided by the depth of the lower vertebra to generate a dimensionless ratio unaffected by magnification differences.
Craniovertebral posture was evaluated using the NSL/OPT and OPT/HOR angles. For the NSL/OPT angle, the landmarks Nasion (N), Sella (S), cv2tg (the posterosuperior tangent point of the odontoid process of C2), and cv2ip (the posteroinferior point of the C2 vertebral body) were identified, and the angle between the NSL and OPT lines was measured. The OPT/HOR angle was defined as the angle between the true horizontal plane and the line tangent to the posterior surface of the odontoid process.
Hyoid triangle height was determined using a triangle formed by the most anterosuperior point of the hyoid bone (H), the anteroinferior point of the third cervical vertebra (C3ia), and retrognathion (RGN). All cephalometric measurements were performed using AudaxCeph software.
Statistical analyses were conducted to investigate the relationship between the obtained measurements and the presence of disc displacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Temporomandibular disorder
Key inclusion criteria (3 listed)
- Presence of TMJ symptoms on at least one side, including pain, abnormal mandibular movements, or joint noises.
- Parafunctional habits such as bruxism or clenching.
- Patients with disc displacement of TMJ.
Key exclusion criteria (8 listed)
- Presence of malformations affecting the craniofacial region.
- History of trauma of the maxillofacial region.
- History of cervical surgery or any procedure involving the cervical region.
- Patients with tumors, cysts, hypoplasia, or hyperplasia in the TMJ region.
- Any condition related to a congenital anomaly or syndrome.
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 |
|---|---|---|
| cephalometric analysiscephalometric analysis | Radiation | – |
Primary outcome
morphologic analysis of cervical vertebrae
Time frame: Start date: April 1, 2026 - End date: June 1, 2026
Morphological measurements of the C2, C3, and C4 vertebral bodies were performed on lateral cephalometric radiographs of the included patients. Morphological assessment included the presence of osteophyte formation and generalized sclerosis of the vertebrae. Osteophytes are marginal bony proliferations arising from the periosteal surface of the vertebral body endplates, typically developing at the anterior and lateral aspects as a reactive response to chronic mechanical stress and intervertebral disc degeneration. Radiologically, they appear as well-defined osseous outgrowths that may vary in size and orientation and can occasionally contribute to adjacent soft tissue or neural structure compression depending on their extent. Generalized sclerosis refers to a diffuse increase in bone density involving the vertebral bodies, characterized radiologically by homogeneous or heterogeneous areas of increased radiopacity on imaging studies.
vertebral dimension measurements and intervertebral disc height
Time frame: Start date: April 1, 2026 - End date: June 1, 2026
Anterior and posterior vertebral heights were defined as the distances between the superior and inferior borders of the anterior and posterior margins of the vertebral body. Anteroposterior diameter of C2, C3, and C4 was measured as vertebral depth, and the anterior height/depth ratio was calculated to obtain a dimensionless value independent of radiographic magnification. Anterior intervertebral disc height was determined by summing the perpendicular distances from the inferoanterior corner of the upper vertebra and the superoanterior corner of the lower vertebra to the angle bisector constructed between these points. This value was divided by the depth of the lower vertebra to obtain a magnification-independent ratio.
1 secondary outcome
cervical posture evaluation
Time frame: Start date: April 1, 2026 - End date: June 1, 2026
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 3 Aug 2026.
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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 Disorder (TMD) and Cervical Vertebrae, 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 3 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 3 Aug 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?
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?
morphologic analysis of cervical vertebrae (time frame: Start date: April 1, 2026 - End date: June 1, 2026). The study lists 2 primary outcomes in all. 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 3 Aug 2026.