Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
NCT ID: NCT06790628
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2025-02-01
2026-12-31
Brief Summary
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Detailed Description
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Design:
A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.
Population:
Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.
Interventions:
Group 1: Fibula free flap fixated at the alveolar level (prosthetically favorable position).
Group 2: Fibula free flap fixated at the inferior border level (conventional position).
Setting:
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.
Duration:
Follow-up over 12 months post-surgery, with key data collection points at baseline, 3 days, 1 week, 1 month, 6 months, and 12 months postoperatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mandibular reconstruction with fibula free flap fixated in inferior border level.
Fixation of the fibula in the inferior border level (conventional position).
Fibula free flap
surgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants.
The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration.
The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction.
Mandibular reconstruction with fibula free flap fixated in the alveolar level.
Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth.
Fibula free flap
surgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants.
The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration.
The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction.
Interventions
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Fibula free flap
surgical technique used in reconstructive surgery where a segment of the fibula bone, along with its blood vessels, is taken from the lower leg and transplanted to reconstruct defects in the mandible due to its length, strength, and ability to support dental implants.
The blood vessels are connected to nearby vessels at the reconstruction site to ensure the bone's survival and integration.
The procedure is highly versatile and often referred to as the "gold standard" for mandibular reconstruction.
Eligibility Criteria
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Inclusion Criteria
* Patient with Mandibular defect \>9 cm.
Exclusion Criteria
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Ibrahim Ahmed Sakr
Ph.D. Candidate in Oral & Maxillofacial surgery departement.
Locations
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Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery
Role: CONTACT
Other Identifiers
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OMFS 3-3-60
Identifier Type: -
Identifier Source: org_study_id
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