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Digital sensor maps how jaw surgery moves the jaw joint

NCT ID NCT07828041

Knowledge-focused Sponsor: Semmelweis University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers at Semmelweis University are studying how orthognathic surgery, which realigns the upper and lower jaws, affects the temporomandibular joint and jaw movement. Fifty adults aged 18 to 45 with severe dentofacial deformities take part. Using a digital facebow device called Arcus Digma III, the team measures three-dimensional condylar displacement and the maximum range of jaw motion before and after surgery. The goal is to understand how these operations change the jaw joint and its movement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
jaw-realignment surgery (orthognathic surgery) tracked with a digital mandibular movement analyzer
What this could lead to
If the tracking shows how jaw-realignment surgery shifts the joint and changes jaw movement, surgeons could plan these operations to protect the temporomandibular joint and lower the chance of jaw-joint problems afterward.
What could go wrong
This is a small observational study of 50 adults, so its measurements may not apply to everyone. It tracks changes after surgery but cannot prove that the surgery causes them, and jaw surgery itself carries risks such as nerve numbness, infection, and joint discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Malocclusion temporomandibular joint disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malocclusions TMD/orofacial pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Semmelweis University Department of Paediatric Dentistry and Orthodontics

    RECRUITING

    Budapest, 1088, Hungary

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