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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular reconstruction with fibula free flap fixated in inferior border level. | Active Comparator | Fixation of the fibula in the inferior border level (conventional position). |
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| Mandibular reconstruction with fibula free flap fixated in the alveolar level. | Active Comparator | Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibula free flap | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Facial Symmetry | 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. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction. | Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10) | 6-12 months |
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Inclusion Criteria:
Exclusion Criteria:
- Patients with systemic condition counteracting with the surgical procedure.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery | Contact | +201097891973 | mohamedsakr@dentistry.cu.edu.eg | |
| Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery | Contact | +20 10 18871899 | a.abouelfetouh@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral & Maxillofacial department - Faculty of Dentistry - Cairo University. | Recruiting | Cairo | Cairo Governorate | 11553 | Egypt |
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Randomized Controlled Trial
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