Actively Recruiting
Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry: A Prospective Clinical Trial
Led by Cairo University · Updated on 2025-06-11
8
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and effectiveness of patient-specific plates (PSPs) designed through virtual surgical planning (VSP) for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. This prospective clinical trial focuses on how well the actual surgery matches the planned virtual surgery and how satisfied participants are with their appearance after the procedure. The study addresses challenges in traditional surgery by using 3D planning and custom devices tailored to each patient's anatomy. Participants will undergo detailed CT scans to create 3D models of their craniofacial structure. Custom titanium plates and cutting guides are designed and manufactured using 3D printing and milling techniques. Surgery involves precise bone cuts guided by these tools to reposition the upper jaw as planned. The study includes a follow-up period of six months to monitor healing and assess outcomes. During the trial, participants will have multiple CT scans to compare the planned surgical corrections with the actual results. Researchers will evaluate the accuracy of bone repositioning by superimposing images taken before and after surgery at intervals of 1 week, 1 month, 3 months, and 6 months. They will also assess aesthetic results and participant satisfaction. Postoperative care and follow-up visits are standardized to ensure consistent monitoring throughout the study period.
CONDITIONS
Brief Title
Assessment of the Accuracy of Patient Specific Plates for Correction of Maxillary Cant in Facial Asymmetry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Presence of maxillary cant
- Presence of facial asymmetry
You will not qualify if you...
- Diagnosis of craniofacial syndrome
- History of maxillofacial tumors
- History of facial trauma
- Presence of cleft lip and/or palate
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 - 1 day (surgery) plus immediate recovery period
Participants undergo orthognathic surgery using Virtual Surgical Planning (VSP) combined with custom-fabricated Patient-Specific Plates (PSPs) for precise correction of maxillary cant. This includes preoperative 3D imaging, virtual planning, and the use of 3D-printed surgical guides and personalized fixation plates during surgery.
1 surgical visit (in-person)
Duration - 6 months
Participants receive standardized postoperative care including antibiotics, analgesics, and steroids, along with structured follow-up visits to assess surgical accuracy, aesthetic outcomes, and patient satisfaction.
Visits at 1 week, 1 month, 3 months, and 6 months post-surgery (in-person)
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Cairo University
Cairo, Egypt, 11562
Actively Recruiting
Research Team
A
abdulqadr M al-hawaagi, M.Sc.
M
Mohamed A Shehab, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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