Actively Recruiting
Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2025-04-02
28
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the accuracy of a splintless virtual surgical plan using a mandible-first technique in orthognathic surgery for patients with dentofacial deformities. The study aims to compare the post-operative three-dimensional CT scans with the digital surgical plans to evaluate the precision of this approach. The study is observational and focuses on surgical accuracy after the procedure. Participants will undergo bimaxillary osteotomy involving a Maxillary LeFort I osteotomy and mandible osteotomy (BSSO) without using an intermediate splint. This surgical method is the main procedure being observed. The study does not include any drug treatments or placebo. After surgery, participants will be monitored with a primary outcome measure of accuracy evaluation using three-dimensional imaging one month post-operation. Participants will be involved in post-operative CT scans and clinical assessments to track the surgical results. The total duration of participation includes the surgery and the one-month follow-up for accuracy assessment.
CONDITIONS
Brief Title
Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Aged over 18 and under 60 years
- Diagnosis of dento-skeletal dysmorphosis involving the middle and lower parts of the face
- Patients who have given consent to surgery
- Patients in good general health based on medical evaluation and clinical examination
You will not qualify if you...
- History of previous maxillomandibular fracture
- Treatment with anticoagulant drugs
- Treatment with intravenous bisphosphonates
- Treatment with anticonvulsants
- Inability to maintain home hygiene standards as required by the study
- History of drug or alcohol abuse
- Chronic corticosteroid therapy
- Radiotherapy, chemotherapy, or immunosuppressive treatment within the last 5 years
- Psychosis
- Pregnant or breastfeeding
- Poor compliance with study requirements
- Endocrine disorders not well controlled with medication
- Other uncontrolled systemic conditions preventing surgery
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.
1 visit (in-person)
Duration - Surgery day and initial recovery period
Participants undergo bimaxillary osteotomy surgery without an intermediate splint and receive immediate post-operative care.
1 surgical visit and immediate post-operative observation
Duration - 1 month post-operation
Participants are monitored to evaluate the accuracy of the surgical procedure and recovery progress.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan, Italy, 20157
Actively Recruiting
Research Team
A
Alessandro Baj, Prof
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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