Creating 3D models to improve orthognathic surgery outcomes
Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06714747
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Emilia-Romagna) |
| Trial ID | NCT06714747 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for orthognathic surgery and have undergone the necessary preoperative imaging.
Not a fit: Patients with cleft lip-palate, facial malformations, or those who have had previous facial augmentations may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Emilia-Romagna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orthognathic Surgery