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Simulation of Facial Soft Tissue in Orthognathic Surgery

Simulation of Facial Soft Tissue in Orthognathic Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06822127
Acronym
SPOC
Enrollment
30
Registered
2025-02-12
Start date
2025-04-28
Completion date
2027-10-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthognathic Surgery

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.

Interventions

OTHERCT scan

6 months postop CT scan

OTHERVLASTIC test

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

Sponsors

University Grenoble Alps
CollaboratorOTHER
Centre Hospitalier Annecy Genevois
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

A non-controlled, non-randomised interventional cohort study of patients undergoing planned orthognathic surgery, designed to evaluate the simulation of changes to the soft parts of the face during surgery, using the SPOC simulation model.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Validation of the predictions provided by the digital face model (SPOC).6 months after orthganthic surgeryCorrelation 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.

Countries

France

Contacts

Primary ContactMarion GHIDI
mghidi@ch-annecygenevois.fr+33450637031
Backup ContactMarion BEUCHER
mbeucher@ch-annecygenevois.fr+33450637032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026