An observational study in TMD/Orofacial Pain and Malocclusions, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Semmelweis University · Observational
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 50 is below the median of 63 across 74 observational studies indexed under Malocclusion.
Browse Malocclusion studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients diagnosed with dentofacial deformities undergoing combined orthodontic and orthognathic surgical treatment (e.g., bilateral sagittal split osteotomy, Le Fort I osteotomy, or bimaxillary surgery). Participants undergo preoperative and postoperative clinical and functional assessments of the temporomandibular joint (TMJ), including mandibular motion, condylar position analysis, and evaluation of temporomandibular signs and symptoms.
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 postoperatively
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 postoperatively
Plan to share: Undecided
Started Sep 2024 (actual). Primary completion is estimated for Dec 2027, 39 months after the start.
Of 32 observational studies under Malocclusion, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 39 months is above that.
How these figures are worked out, and which studies are left out of them.
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