How jaw surgeries affect the jaw joint, using a movement device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers observe jaw joint motion and condyle position with a digital facebow device (Arcus Digma III) before and after orthognathic surgery. The study is observational and focuses on patients undergoing combined orthodontic and jaw surgery. Data collected will include pre- and postoperative measurements to understand changes in temporomandibular joint function. Participation requires presurgical planning, follow-up visits, and informed consent. No interventions beyond standard surgical care are performed for the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Ability and willingness to attend all scheduled preoperative and postoperative follow-up visits

Exclusion Criteria:

* 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
* Active neurological or neuromuscular disorders affecting jaw movement or motor control
* Current use of medications significantly altering bone metabolism or neuromuscular function
* Pregnancy or lactation at the time of enrollment
* Severe unmanaged bruxism or acute trauma to the maxillofacial region within the past 12 months

Where it's running

• Semmelweis University Department of Paediatric Dentistry and Orthodontics
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Lorincz Gergely, medical
• Email: lorincz.gergely@semmelweis.hu
• Phone: +36306640386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.