Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSemmelweis University
About this trial
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older (skeletally mature patients)
Severe dentofacial deformity requiring combined orthodontic and orthognathic surgical treatment
Presurgical orthodontic preparation completed or scheduled for orthognathic surgery
Signed written informed consent prior to study enrollment
Disqualifiers
History of previous orthognathic or major craniofacial surgical interventions
Congenital craniofacial anomalies, cleft lip and/or palate, or genetic syndromes affecting the musculoskeletal or facial skeleton
Pre-existing severe degenerative temporomandibular joint disease (e.g., advanced osteoarthritis, idiopathic condylar resorption, or ankylosis)
Systemic rheumatologic, autoimmune, or connective tissue disorders affecting bone and joint metabolism
Trial population
The study population consists of adult male and female patients diagnosed with skeletal dentofacial deformities who are referred to and treated at the Department of Pediatric Dentistry and Orthodontics in collaboration with the Department of Oro-Maxillofacial Surgery and Stomatology at Semmelweis University (Budapest, Hungary). Eligible participants are consecutive patients undergoing combined orthodontic and orthognathic surgical treatment who fulfill the predefined inclusion criteria and agree to participate in the prospective functional evaluation of the temporomandibular joint and mandibular kinematics.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Orthognathic Surgery Cohort
Trial outcomes
Primary outcomes
1
Change in Mandibular Condylar Displacement Between Centric Relation and Maximum Intercuspation Measured by Arcus Digma 3 in Millimeters
The three-dimensional spatial discrepancy (shift/displacement) of the mandibular condyle between centric relation (CR) and maximum intercuspation (MIP), measured in millimeters (along the X, Y, and Z spatial coordinates and as a 3D vector length) using the Arcus Digma III mandibular motion alanyzer device .
Time frame
Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively2
Change in Mandibular Maximum Range of Motion Measured by Arcus Digma 3 in Millimeters
Mandibular maximum range of motion, including maximum mouth opening, protrusion, and right and left lateral excursions, recorded in millimeters using the Arcus Digma 3.
Time frame
Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov