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NCT Number: NCT06822127

Simulation of Facial Soft Tissue in Orthognathic Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy Genevois

Annecy, 73330, France

Location status: Recruiting

Location contact

Georges BETTEGA, MD

CONTACT

[email protected]

+33 ext. 4 50 63 60 72

Georges BETTEGA, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT scan

Other

6 months postop CT scan

VLASTIC test

Other

Measurement of the elasticity of the facial integument using the VLASTIC cutometer (Volume-based Light Aspiration device for in vivo Soft Tissue Characterization)

Primary outcomes

  1. Validation of the predictions provided by the digital face model (SPOC).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marion BEUCHER

CONTACT

[email protected]

+33450637032 ext. +33

Marion GHIDI

CONTACT

[email protected]

+33450637031 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Collaborators

  • University Grenoble Alps

Registry information

Acronym: SPOC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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