TMD/Orofacial PainNCT07828041
Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device
An observational study of TMD/Orofacial Pain and Malocclusions, run by Semmelweis University at 1 site in Hungary.
Trial summary
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMD/Orofacial Pain, Malocclusions
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 18 Sep 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Department of Paediatric Dentistry and Orthodontics
Budapest, 1088
Gergely Lorincz, medical, +36306640386, lorincz.gergely@semmelweis.hu
About this study
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.
- Conditions
- TMD/Orofacial Pain, Malocclusions
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start18 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TMD/Orofacial PainStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828041
- Sponsor's protocol ID
- SE RKEB 249/2024/TMI
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28174061
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Orthognathic Surgeries on the Temporomandibular Joint Using a Mandibular Movement Analyzer Device
- ClinicalTrials.gov ID
- NCT07828041
- Acronym / sponsor ID
- SE RKEB 249/2024/TMI
- Conditions
- TMD/Orofacial Pain, Malocclusions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Condylar position and mandibular motion assessment with digital facebows Arcus Digma III before and after orthognathic surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Mandibular Condylar Displacement Between Centric Relation and Maximum Intercuspation Measured by Arcus Digma 3 in Millimeters
Time frame: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively
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 .
Change in Mandibular Maximum Range of Motion Measured by Arcus Digma 3 in Millimeters
Time frame: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively
Mandibular maximum range of motion, including maximum mouth opening, protrusion, and right and left lateral excursions, recorded in millimeters using the Arcus Digma 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 28174061Te 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TMD/Orofacial Pain and Malocclusions, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorincz Gergely, medical (+36306640386, lorincz.gergely@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mandibular Condylar Displacement Between Centric Relation and Maximum Intercuspation Measured by Arcus Digma 3 in Millimeters (time frame: Baseline (preoperative, within 4 weeks prior to surgery) and at 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07828041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.