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

NCT07828041 | Recruiting

• 1 other identifier: SE RKEB 249/2024/TMI
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malocclusions; TMD/Orofacial Pain

Outcome Measures

Primary Outcomes (2)

• 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 .

  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.

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

Study Arms (1)

Orthognathic Surgery Cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Department of Paediatric Dentistry and Orthodontics

Budapest, 1088, Hungary

RECRUITING

Related Publications (1)

• Te Veldhuis EC, Te Veldhuis AH, Bramer WM, Wolvius EB, Koudstaal MJ. The effect of orthognathic surgery on the temporomandibular joint and oral function: a systematic review. Int J Oral Maxillofac Surg. 2017 May;46(5):554-563. doi: 10.1016/j.ijom.2017.01.004. Epub 2017 Feb 4.

  PMID: 28174061 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Lorincz Gergely, medical

CONTACT

+36306640386; lorincz.gergely@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 18, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-06

Locations

HU (1)