Mandibular Reconstruction With Axially Vascularised Bone Substitutes
Recruiting now · Not applicable
Conditions studied: Mandibular Deficiency
In brief
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.
Key facts
- Study ID
- NCT04001842
- Run by
- University of Alexandria
- People needed
- 10
- Starts
- 2019-07-01
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2024-12-05
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Faculty of Medicine, University of Alexandria — Alexandria, Egypt (enrolling)
Full record on ClinicalTrials.gov
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