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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02357-40 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| University Grenoble Alps | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Other | 6 months postop CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion GHIDI | Contact | +33450637031 | +33 | mghidi@ch-annecygenevois.fr |
| Marion BEUCHER | Contact | +33450637032 | +33 | mbeucher@ch-annecygenevois.fr |
| Name | Affiliation | Role |
|---|---|---|
| Georges BETTEGA | Centre Hospitalier Annecy Genevois | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy Genevois | Recruiting | Annecy | 73330 | France |
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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.
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| 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) |
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