Simulation of Facial Soft Tissue in Orthognathic Surgery (SPOC)

Centre Hospitalier Annecy Genevois

Status: Enrolling

Conditions: Orthognathic Surgery

Treatments: Other: CT scan; Other: VLASTIC test

Study type: Interventional

Funder types: Other

Identifiers

NCT06822127

2024-A02357-40 (Other Identifier)

24-02

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients undergoing orthognathic surgery,

Other group

Description:

Patients undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty, whatever the indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.)

Treatment:

Other: VLASTIC test

Other: CT scan