Mandible Reconstruction
Conditions
Keywords
Segmental mandibular defect, mandibular reconstruction, fibula free flap, dental implants, facial symmetry, face scan.
Brief summary
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
PROCEDUREFibula 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Symmetry | 6-12 months | Tool: 3D Stereophotogrammetry face scan. Unit: RMSD: root mean square deviation (Millimeters). Method: superimposition of the face scan color maps on Materialise's Interactive Medical Image Control System (MIMICS) Software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction. | 6-12 months | Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10) |
Countries
Egypt
Contacts
Primary ContactMohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery
Backup ContactAdel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery
Outcome results
None listed