NCT06822127 Simulation of Facial Soft Tissue in Orthognathic Surgery
| NCT ID | NCT06822127 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Annecy Genevois |
| Condition | Orthognathic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-28 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect. The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.
Eligibility Criteria
Inclusion Criteria: * Patient over 18 ; * Patients who have been informed of the study and who have freely given their informed consent to participate in the study; * Patient undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.); * Patient covered by a French social security scheme Exclusion Criteria: * Patient with maxillary disjunction ; * Patients with facial malformations; * Pregnant or breast-feeding patient; * Patient under guardianship; * Patients who do not understand French; * Patients under court protection * No pre- or postoperative CT scan or CT scan that cannot be used * Surgery, trauma, progressive infection or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
Contact & Investigator
Georges BETTEGA
PRINCIPAL INVESTIGATOR
Centre Hospitalier Annecy Genevois
Frequently Asked Questions
Who can join the NCT06822127 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Orthognathic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822127 currently recruiting?
Yes, NCT06822127 is actively recruiting participants. Contact the research team at mghidi@ch-annecygenevois.fr for enrollment information.
Where is the NCT06822127 trial being conducted?
This trial is being conducted at Annecy, France.
Who is sponsoring the NCT06822127 clinical trial?
NCT06822127 is sponsored by Centre Hospitalier Annecy Genevois. The principal investigator is Georges BETTEGA at Centre Hospitalier Annecy Genevois. The trial plans to enroll 30 participants.