Actively Recruiting
Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-04
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying orthognathic surgery to correct dento-skeletal irregularities such as Class II, Class III, or facial asymmetries. The goal is to improve both function and appearance of the face, which are equally important. Traditional planning includes an orthodontic presurgical phase, but current knowledge mainly comes from two-dimensional studies, which lack full realism since the face and surgery occur in three dimensions. This research focuses on using anatomically accurate 3D virtual models to better predict soft tissue changes after bone movements in the maxilla and mandible during orthognathic surgery. New 3D methods like digital stereophotogrammetry, CT, MRI, and ECO-3D help capture facial and skeletal structures more precisely. While existing software predicts bone and teeth changes well, it is less reliable for soft tissue simulation due to biomechanical complexity. Participants in this observational study undergo orthognathic surgery and preoperative imaging with CBCT and MRI. Researchers collect data before and after surgery, including teleradiography and orthopantomography, to study facial changes over 18 months. Outcomes focus on both primary and secondary measures during this period. The study aims to enhance understanding of facial soft tissue responses to surgery for improved planning and results.
CONDITIONS
Brief Title
Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI
- Patients aged 18 years or older
- Obtaining informed consent
- Patients with preoperative teleradiography and orthopantomography
You will not qualify if you...
- Patients with cleft lip-palate, facial malformations, or related syndromes such as Apert, Crouzon, Ofeiffer, or Treacher Collins syndrome
- Patients who have had Medpor prosthesis or ancillary facial procedures like lipofilling, fillers, or polyethylene ketone prostheses
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to surgery date
Participants undergo preoperative radiographic studies including CBCT, MRI, teleradiography, and orthopantomography to collect detailed 3D images of facial structures before surgery.
1 to 2 visits depending on imaging requirements
Duration - Surgery day and days following until discharge
Participants undergo orthognathic surgery followed by immediate post-operative care to monitor recovery and initial outcomes.
1 surgical visit plus post-operative visits as needed
Duration - 18 months
Participants are monitored for up to 18 months after surgery to assess soft tissue changes and surgical outcomes.
Regular follow-up visits over 18 months
Trial Site Locations
Total: 1 location
1
IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
Research Team
C
Claudio Marchetti, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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