- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429435
Morphometric and Morphological Analysis of Cervical Vertebrae in Disc Displacement (TMJ)
Imaging-Based Morphometric and Morphological Analysis of Cervical Vertebrae in Patients With TMJ Disc Displacement
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Start date: April 1, 2026 - End date: June 1, 2026
|
|
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.
|
Start date: April 1, 2026 - End date: June 1, 2026
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cervical posture evaluation
Time Frame: Start date: April 1, 2026 - End date: June 1, 2026
|
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).
|
Start date: April 1, 2026 - End date: June 1, 2026
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBUADCR01 (Other Identifier: KSBU BİLİMSEL ARAŞTIRMA PROJELERİ KOORDİNASYON BİRİMİ)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dentistry
-
Sigmund Freud PrivatUniversitatUniversity of Chile; University of FreiburgEnrolling by invitation
-
Proed, Torino, ItalyRecruitingImplant DentistryItaly
-
Ain Shams UniversityRecruiting
-
National Taiwan University HospitalRecruitingEducation | DentistryTaiwan
-
Al-Azhar UniversityCompleted
-
Trakya UniversityCompleted
-
British University In EgyptCompletedPediatric DentistryEgypt
-
Geisinger ClinicCompleted
-
Professor David BearnNHS TaysideTerminatedPaediatric DentistryUnited Kingdom
-
University of Colorado, DenverWithdrawnPediatric DentistryUnited States
Clinical Trials on cephalometric analysis
-
Andrea ScribanteCompletedMarfan Syndrome | Loeys-Dietz SyndromeItaly
-
Andrea ScribanteCompletedSkeletal MalocclusionItaly
-
International Islamic University MalaysiaCompletedOrthodontic | Cephalometric Analysis | CephalometryMalaysia
-
Al-Azhar UniversityNot yet recruiting
-
University of PaviaNot yet recruitingTooth Abnormalities | Congenital Cataract | Ocular PathologiesItaly
-
The Cleveland ClinicRecruiting
-
Mohamed Abd El-GhafourActive, not recruitingCorrelation Between Second Molar Calcification Stage and CVMI for Skeletal Maturation Assessment in Egyptian PopulationEgypt
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenCompletedMalocclusion | Orthodontics | Cone-Beam Computed Tomography | Panoramic Radiography | Impacted Tooth | CephalometryBelgium
-
Damascus UniversityCompletedImpacted CaninesSyrian Arab Republic
-
Kutahya Health Sciences UniversityCompletedUltrasonography | Masseter | Cephalometry | MalocclusionsTurkey