NCT06790628

Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Mandible Reconstruction

Interventions

Type	Name	Description
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 reconstruction.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2025-01-24
• Last updated: 2025-02-28

Locations

1 site across 1 country: Egypt