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

NCT ID: NCT06790628

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Mandible Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Fibula free flap

Intervention Type 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 the alveolar level.

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

Group Type ACTIVE_COMPARATOR

Fibula free flap

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ibrahim Ahmed Sakr

Ph.D. Candidate in Oral & Maxillofacial surgery departement.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Ibrahim Sakr, MSc Oral&Maxillofacial Surgery

Role: CONTACT

+201097891973

Adel Hamdy Abou Elfetouh, ProfOral&Maxillofacial Surgery

Role: CONTACT

+20 10 18871899

Other Identifiers

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OMFS 3-3-60

Identifier Type: -

Identifier Source: org_study_id

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