RecruitingNot ApplicableNCT04001842

Mandibular Reconstruction With Axially Vascularised Bone Substitutes

Mandibular Reconstruction Using Tissue Regeneration With Axially Vascularised Bone Substitutes


Sponsor

University of Alexandria

Enrollment

10 participants

Start Date

Jul 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Mandibular reconstruction is necessary following trauma, tumour resections and extensive infections resulting in severe defects of the mandibular arch. For reconstructing large and recurrent defects, the vascularized free flaps are currently regarded as the gold standard. The use of these flaps, however, presents several major inconveniences. Although regenerative medicine in the field of cranio-maxillofacial reconstruction has now become a common practice, the main technical challenge is still related to vascularization of the regenerated tissue in large defects. Axial vascularization of constructs using a microvascular arteriovenous fistula/loop (AV loop) aims at providing the construct with blood supply through a defined and dedicated vascular axis. This technique was successfully demonstrated in some case reports, but was never applied in the craniofacial region. The current study aims to apply and assess the technique of axial vascularization using the AV loop of a bone substitute to reconstruct mandibular defects.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This surgical study tests a new technique to rebuild the jawbone (mandible) after it has been severely damaged or removed due to tumors, trauma, or serious infections. The approach uses a specially designed blood vessel loop (arteriovenous loop) to grow new bone inside a scaffold placed in the jaw, avoiding the need to harvest large amounts of tissue from elsewhere in the body. You may be eligible if you are 18–65 years old, need jaw reconstruction with a defect of 6 cm or more, and do not have uncontrolled chronic illness or active cancer. Participation involves surgery, follow-up imaging over 6–9 months, and possible dental implants once healing is complete. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSurgical reconstruction of the mandible using an axially vascularized bone construct

Surgically reconstructing defects of the mandible using reconstruction plate and Titanium mesh filled with an artificial bone substitute to form a bone construct. This construct will be vascularized at the same operation using a vein graft from the forearm. The vein graft will be microsurgically connected to an artery and vein within the facial/neck region to provide a vascular supply to the construct (arterio venous loop)


Locations(1)

Faculty of Medicine, University of Alexandria

Alexandria, Egypt

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NCT04001842


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