Mandibular Reconstruction With Axially Vascularised Bone Substitutes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Alexandria

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Surgical reconstruction of the mandible using an axially vascularized bone construct

    Other intervention

    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)

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Axially vascularized constructsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6-9 months

Secondary outcomes

1

Dental rehabilitation

Implantation of osteointegrated implants within the former defect

Time frame
9 months

Other outcomes

Sponsors and contacts

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