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.

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).

Study Overview

• Status: Recruiting
• Conditions: Mandible Reconstruction
• Intervention / Treatment: Procedure: Fibula free flap

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery; Phone Number: +201097891973; Email: mohamedsakr@dentistry.cu.edu.eg
• Study Contact Backup: Name: Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery; Phone Number: +20 10 18871899; Email: a.abouelfetouh@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • Oral & Maxillofacial department - Faculty of Dentistry - Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mandibular reconstruction with fibula free flap fixated in inferior border level.; Fixation of the fibula in the inferior border level (conventional position).	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.
Active Comparator: Mandibular reconstruction with fibula free flap fixated in the alveolar level.; Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction.	Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10)	6-12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: dental implants; mandibular reconstruction; fibula free flap; facial symmetry; Segmental mandibular defect; face scan.
• Other Study ID Numbers: OMFS 3-3-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No