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NCT Number: NCT07828041

Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device

Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University Department of Paediatric Dentistry and Orthodontics

Budapest, 1088, Hungary

Location status: Recruiting

Location contact

Gergely Lorincz, medical

CONTACT

[email protected]

+36306640386

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 45 years (skeletally mature patients). Severe dentofacial deformity requiring combined orthodontic and orthognathic surgical treatment (e.g., Le Fort I osteotomy, bilateral sagittal split osteotomy, or bimaxillary procedure).

Presurgical orthodontic preparation completed or near completion. 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 (e.g., rheumatoid arthritis, lupus).

Active neurological or neuromuscular disorders affecting jaw movement or motor control.

Current use of medications significantly altering bone metabolism or neuromuscular function (e.g., chronic systemic corticosteroids, antiresorptive agents).

Severe unmanaged bruxism or acute trauma to the maxillofacial region

Treatment and study plan

Primary outcomes

  1. Change in Three-Dimensional Condylar Displacement

    Time frame: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively

  2. Change in Mandibular Maximum Range of Motion

    Time frame: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Lorincz Gergely, medical

CONTACT

[email protected]

+36306640386

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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