Mandibular Reconstruction With Axially Vascularised Bone Substitutes (NCT04001842) | Clinical Trial Compass
RecruitingNot Applicable
Mandibular Reconstruction With Axially Vascularised Bone Substitutes
Egypt10 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiological and histological evidence of bone formation in the mandibular defect