Actively Recruiting
Simulation of Facial Soft Tissue in Orthognathic Surgery
Led by Centre Hospitalier Annecy Genevois · Updated on 2025-11-17
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Annecy Genevois
Lead Sponsor
U
University Grenoble Alps
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a digital face model called SPOC to predict facial soft tissue changes after orthognathic surgery, which rebalances the position of the jaws based on functional and aesthetic needs. This study aims to compare the simulation results from the SPOC algorithm with the actual facial appearance observed on scans taken six months after surgery. The study addresses patients' concerns about post-operative facial changes and hopes to improve pre-surgical visual expectations. Participants undergo orthognathic surgery involving the lower jaw, upper jaw, or both, sometimes combined with genioplasty, for various conditions such as occlusal disorders, sleep apnea syndrome, or joint dysfunction. The study uses pre- and six-month post-operative CT scans along with a facial elasticity test called the VLASTIC cutometer to assess soft tissue changes and validate the digital model's predictions. During the study, participants will have a CT scan six months after surgery and measurements of facial tissue elasticity using the VLASTIC device. Researchers will compare these results to the predicted outcomes from the digital model to evaluate its accuracy. The primary outcome is the validation of the SPOC model's predictions six months post-surgery, helping to improve patient information and surgical planning.
CONDITIONS
Brief Title
Simulation of Facial Soft Tissue in Orthognathic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Patients who have been informed and freely consented to participate
- Patients undergoing isolated mandibular or maxillary orthognathic surgery, or combined maxillo-mandibular surgery with or without genioplasty for any indication
- Patients covered by a French social security scheme
You will not qualify if you...
- Patients with maxillary disjunction
- Patients with facial malformations
- Pregnant or breastfeeding patients
- Patients under guardianship or court protection
- Patients who do not understand French
- Patients without usable pre- or postoperative CT scans
- Patients who have had surgery, trauma, infection, or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo orthognathic surgery including isolated mandibular or maxillary surgery, or combined maxillo-mandibular surgery with or without genioplasty.
1 visit (surgery day)
Duration - 6 months after surgery
Participants are followed up to measure facial soft tissue elasticity and to validate digital face model predictions.
1 visit (in-person) at 6 months post-operation
Trial Site Locations
Total: 1 location
1
CH Annecy Genevois
Annecy, France, 73330
Actively Recruiting
Research Team
M
Marion GHIDI
M
Marion BEUCHER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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