Orthognathic SurgerySPOCNCT06822127
Simulation of Facial Soft Tissue in Orthognathic Surgery
A study testing CT scan and VLASTIC test in people with Orthognathic Surgery, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- CT scan and VLASTIC test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH Annecy Genevois
Annecy, 73330
Georges BETTEGA, MD, +33 ext. 4 50 63 60 72, gbettega@ch-annecygenevois.fr
Georges BETTEGA, MD
About this study
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
- Orthognathic Surgery
- Being tested
- CT scan, VLASTIC test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanOther
6 months postop CT scan
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)
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Other: CT scan; Other: VLASTIC test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after orthganthic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start28 Apr 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Georges BETTEGA, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822127
- Sponsor's protocol ID
- 24-02
- Other IDs
- 2024-A02357-40
- Acronym
- SPOC
- Status last verified
- Nov 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation of Facial Soft Tissue in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT06822127
- Acronym / sponsor ID
- SPOC / 24-02
- Conditions
- Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- University Grenoble Alps
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing orthognathic surgery, | Other | Other: CT scan, Other: VLASTIC testPatients 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patient with maxillary disjunction ;
- Patients with facial malformations;
- Pregnant or breast-feeding patient;
- Patient under guardianship;
- Patients who do not understand French;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scan6 months postop CT scan | Other | Patients undergoing orthognathic surgery, |
| VLASTIC testMeasurement of the elasticity of the facial integument using the VLASTIC cutometer (Volume-based Light Aspiration device for in vivo Soft Tissue Characterization) | Other | Patients undergoing orthognathic surgery, |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georges BETTEGA principal investigator
Centre Hospitalier Annecy Genevois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and VLASTIC test in people with Orthognathic Surgery, run by Centre Hospitalier Annecy Genevois at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion GHIDI (+33450637031 ext. +33, mghidi@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the predictions provided by the digital face model (SPOC). (time frame: 6 months after orthganthic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.