Facial soft-tissue simulation for corrective jaw surgery
Simulation of Facial Soft Tissue in Orthognathic Surgery
We will test a computer tool that simulates how your face might look after orthognathic (jaw) surgery for adults planning corrective jaw operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Annecy Genevois Academic / other |
| Locations | 1 site (Annecy) |
| Trial ID | NCT06822127 on ClinicalTrials.gov |
What this trial studies
This interventional project uses preoperative and postoperative CT scans together with a software-based VLASTIC test to model soft-tissue changes after isolated mandibular, maxillary, or combined maxillo-mandibular orthognathic surgery. Surgeons will apply three-dimensional bone displacement data to generate soft-tissue simulations and then compare those predictions with actual postoperative CT-derived anatomy. The study enrolls adults treated at CH Annecy Genevois who can provide informed consent and have usable CT scans before and after surgery. The goal is to improve simulation accuracy so patients and clinicians can better anticipate postoperative facial appearance.
Who should consider this trial
Good fit: Adults (18+) undergoing isolated mandibular, maxillary, or combined maxillo-mandibular orthognathic surgery at CH Annecy Genevois who can give informed consent, speak French, are covered by French social security, and have usable pre- and planned postoperative CT scans are ideal candidates.
Not a fit: Patients with maxillary disjunction, congenital facial malformations, those who will have additional facial surgery/trauma/injections before the postoperative scan, those without usable CTs, non-French speakers, pregnant or legally protected individuals are unlikely to benefit.
Why it matters
Potential benefit: If successful, the tool could give patients a more accurate visual preview of their postoperative facial appearance and help improve surgical planning.
How similar studies have performed: Three-dimensional bone-planning is well established, but precise soft-tissue prediction remains limited and similar software approaches have shown mixed or only partial success in prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Annecy
- CH Annecy Genevois — Annecy, France (Recruiting)
Study contacts
- Principal investigator: Georges BETTEGA — Centre Hospitalier Annecy Genevois
- Study coordinator: Marion GHIDI
- Email: mghidi@ch-annecygenevois.fr
- Phone: +33450637031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.