Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06822127

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

130 weeks

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

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.

CONDITIONS

Official Title

Simulation of Facial Soft Tissue in Orthognathic Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years old
  • Patient has been informed about the study and has freely given informed consent
  • Scheduled for isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication
  • Covered by a French social security scheme
Not Eligible

You will not qualify if you...

  • Patient with maxillary disjunction
  • Patient with facial malformations
  • Pregnant or breastfeeding patient
  • Patient under guardianship
  • Patient who does not understand French
  • Patient under court protection
  • No pre- or postoperative CT scan or unusable CT scan
  • Surgery, trauma, progressive infection, or cosmetic injection on the face after orthognathic surgery and before postoperative scan

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CH Annecy Genevois

Annecy, France, 73330

Actively Recruiting

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Research Team

M

Marion GHIDI

CONTACT

M

Marion BEUCHER

CONTACT

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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