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

Cairo University (CU)

Status: Enrolling

Conditions: Mandible Reconstruction

Treatments: Procedure: Fibula free flap

Study type: Interventional

Funder types: Other

Identifiers

NCT06790628

OMFS 3-3-60

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Mandibular reconstruction with fibula free flap fixated in inferior border level.

Active Comparator group

Description:

Fixation of the fibula in the inferior border level (conventional position).

Treatment:

Procedure: Fibula free flap

Mandibular reconstruction with fibula free flap fixated in the alveolar level.

Active Comparator group

Description:

Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth.

Treatment:

Procedure: Fibula free flap