Simulation of Facial Soft Tissue in Orthognathic Surgery (SPOC)

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.

Study Overview

• Status: Recruiting
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Other: CT scan; Other: VLASTIC test

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion GHIDI; Phone Number: +33 +33450637031; Email: mghidi@ch-annecygenevois.fr
• Study Contact Backup: Name: Marion BEUCHER; Phone Number: +33 +33450637032; Email: mbeucher@ch-annecygenevois.fr

Study Locations

• France
  • Annecy, France, 73330
    • Recruiting
    • CH Annecy Genevois
    • Contact: Georges BETTEGA, MD; Phone Number: 4 50 63 60 72 +33; Email: gbettega@ch-annecygenevois.fr
    • Principal Investigator: Georges BETTEGA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients undergoing orthognathic surgery,; 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.)	Other: CT scan; 6 months postop CT scan; Other: VLASTIC test; Measurement of the elasticity of the facial integument using the VLASTIC cutometer (Volume-based Light Aspiration device for in vivo Soft Tissue Characterization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the predictions provided by the digital face model (SPOC).	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.	6 months after orthganthic surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Collaborators: University Grenoble Alps
• Investigators: Principal Investigator: Georges BETTEGA, Centre Hospitalier Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-02; 2024-A02357-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No