NCT04001842 Mandibular Reconstruction With Axially Vascularised Bone Substitutes
| NCT ID | NCT04001842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alexandria |
| Condition | Mandibular Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2019-07-01 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2019-07-01 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04001842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Mandibular Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04001842 currently recruiting?
Yes, NCT04001842 is actively recruiting participants. Contact the research team at ahmad.eweida@alexmed.edu.eg for enrollment information.
Where is the NCT04001842 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT04001842 clinical trial?
NCT04001842 is sponsored by University of Alexandria. The trial plans to enroll 10 participants.