Creating 3D models to improve orthognathic surgery outcomes
Official title: Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06714747 · Data updated 2026-11-12
This study is testing if using 3D models can help doctors plan better for jaw surgery to improve both how patients look and how well they function afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Status | Recruiting |
| Started | January 11, 2022 |
| Main results expected | September 11, 2026 |
| Study ends | November 11, 2026 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT06714747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled for orthognathic surgery and have undergone the necessary preoperative imaging.
✕Probably not a fit
Patients with cleft lip-palate, facial malformations, or those who have had previous facial augmentations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on enhancing orthognathic surgery by developing anatomically accurate virtual models that predict soft tissue changes resulting from surgical interventions. It aims to address the limitations of traditional 2D imaging techniques by utilizing advanced imaging methods like CBCT and MRI for preoperative assessments. The study will involve patients aged 18 and older who are scheduled for orthognathic surgery, ensuring informed consent and proper radiographic documentation. By improving the planning process, the study seeks to optimize both functional and aesthetic outcomes for patients undergoing these procedures.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical outcomes and improved patient satisfaction in orthognathic surgery.
How similar studies have gone: While the use of 3D modeling in surgical planning is gaining traction, this specific approach in orthognathic surgery is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI * Patients with age \> or = 18 years old * Obtaining informed consent * Patients with preoperative teleradiography and orthopantomography Exclusion Criteria: * patients with cleft lip-palate, facial malformations and/or syndromes (syndromes with involvement of the cephalic extremity, such as sd of Apert. Cropuzon, Ofeiffer, Treacher Collins) * patients who have undergone application of Medpor prostheses or who have undergone ancillary procedures (lipofilling, fillers, volumetric facial augmentations with insertion of polyethylene ketone prostheses)
Where it's running
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IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy Recruiting
Study contacts
- Principal investigator: Claudio Marchetti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Claudio Marchetti, MD
- Email: claudio.marchetti@aosp.bo.it
- Phone: 051 214 3415
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.