Simulation of Facial Soft Tissue in Orthognathic Surgery

Not Applicable

Not yet recruiting

• Conditions: Orthognathic Surgery

• Registration Number: NCT06822127
• Lead Sponsor: Centre Hospitalier Annecy Genevois

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validation of the predictions provided by the digital face model (SPOC).	6 months after orthganthic surgery	Correlation of morphological result simulation of surgery, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the surgery.