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

NCT06790628 | Recruiting DMC

• 1 other identifier: OMFS 3-3-60
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Mandible Reconstruction

Keywords

Segmental mandibular defect; mandibular reconstruction; fibula free flap; dental implants; facial symmetry; face scan.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Patient Satisfaction.

  6-12 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: Fibula free flap

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.

Procedure: Fibula free flap

Interventions

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.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
• Patient with Mandibular defect \>9 cm.

You may not qualify if:

• \- Patients with systemic condition counteracting with the surgical procedure.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.

Cairo, Cairo Governorate, 11553, Egypt

RECRUITING

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Candidate in Oral & Maxillofacial surgery departement.

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

EG (1)