Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fibula free flap.
- Who it may be relevant to
- Registry conditions: Mandible Reconstruction. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Detailed description
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
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.
Interventions
- Procedure 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 reconstruct
Primary outcome measures
- Facial Symmetry [Time frame: 6-12 months]
Secondary outcome measures (1)
- Patient Satisfaction. [Time frame: 6-12 months]
Eligibility criteria
Inclusion criteria
- Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- Patient with Mandibular defect >9 cm.
Exclusion criteria
\- Patients with systemic condition counteracting with the surgical procedure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Oral & Maxillofacial department - Faculty of Dentistry - Cairo University. — Cairo
Identifiers
NCT: NCT06790628 · OMFS 3-3-60