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NCT Number: NCT06790628

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

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Cairo Governorate, 11553, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Facial Symmetry

    Time frame: 6-12 months

    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.

Secondary outcomes

  1. Patient Satisfaction.

    Time frame: 6-12 months

    Tool: Questionnare (Visual analogue scale) Unit: Scale (1-10)

Study contacts

Contact information is provided by the study sponsor or research team.

Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery

CONTACT

[email protected]

+20 10 18871899

Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery

CONTACT

[email protected]

+201097891973

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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