NCT06822127

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2025Oct 2027

First Submitted

Initial submission to the registry

February 11, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

February 11, 2025

Last Update Submit

November 14, 2025

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients undergoing orthognathic surgery,

OTHER

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 scanOther: VLASTIC test

Interventions

CT scanOTHER

6 months postop CT scan

Patients undergoing orthognathic surgery,
VLASTIC testOTHER

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

Patients undergoing orthognathic surgery,

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Annecy Genevois

Annecy, 73330, France

RECRUITING

Study Officials

  • Georges BETTEGA

    Centre Hospitalier Annecy Genevois

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion GHIDI

CONTACT

+33450637031mghidi@ch-annecygenevois.fr

Marion BEUCHER

CONTACT

+33450637032mbeucher@ch-annecygenevois.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 12, 2025

Study Start

April 28, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)