About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients requiring mandibular reconstruction for further dental rehabilitation
Mandibular defect (marginal/segmental) equals or more than 6 cm in largest dimension
Middle age adult (18-65 years)
Radiologically and pathologically documented tumour free mandibular defect
Disqualifiers
Extremes of age (<18 or > 65 years)
Associated uncontrolled chronic illness (Diabetes mellitus, Hypertension, Rheumatoid arthritis, collagen disease, Chronic obstructive pulmonary disease)
Primary reconstruction of a mandibular defect after tumour excision
Trial design
Single group
Treatments tested in this trial
Surgical reconstruction of the mandible using an axially vascularized bone construct
Other interventionSurgically 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)
Treatment groups
Trial outcomes
Primary outcomes
Radiological and histological evidence of bone formation in the mandibular defect
Radiological evidence of bone formation in the mandibular defect via CT scans. Histological evidence of bone formation via bone biopsies during the dental rehabilitation procedure (bone drilling for implants).
Secondary outcomes
Dental rehabilitation
Implantation of osteointegrated implants within the former defect
Sponsors and contacts
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