Actively Recruiting
Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial
Led by Cairo University · Updated on 2025-02-28
26
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating facial symmetry outcomes in patients undergoing mandibular reconstruction using fibula free flaps. This study compares two surgical fixation techniques: placing the fibula flap at the prosthetically favorable alveolar level versus the conventional inferior border level. The trial involves patients needing mandibular reconstruction due to tumors, trauma, or osteomyelitis with defects larger than 9 cm. Participants are randomly assigned to one of two groups. One group receives fibula free flap fixation at the inferior border level, while the other group's flap is fixed at the alveolar level, leaving 15-17 mm space to the opposing teeth. The study follows patients for 12 months after surgery to assess the outcomes of these techniques. Throughout the study, patients are monitored at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively. Researchers measure facial symmetry as the primary outcome and patient satisfaction as a secondary outcome during the 6 to 12 month follow-up. This helps evaluate the effectiveness of the two fixation positions in mandibular reconstruction.
CONDITIONS
Brief Title
Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
You will not qualify if you...
- Patients with systemic condition counteracting with the surgical procedure.
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.
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Duration - 1 week or until discharge
Participants undergo mandibular reconstruction surgery using a fibula free flap fixed at either the prosthetically favorable alveolar level or the conventional inferior border level, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - 12 months
Participants are monitored for facial symmetry and patient satisfaction through scheduled follow-up assessments.
Visits at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.
Cairo, Cairo Governorate, Egypt, 11553
Actively Recruiting
Research Team
M
Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery
A
Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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