Reconstructing the jawbone using a new vascular technique
Mandibular Reconstruction Using Tissue Regeneration With Axially Vascularised Bone Substitutes
This study is testing a new way to rebuild the jawbone for patients with serious injuries or conditions to see if it helps the bone heal better and faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alexandria Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT04001842 on ClinicalTrials.gov |
What this trial studies
This study focuses on reconstructing the mandible in patients with significant defects due to trauma, tumors, or infections. It employs a novel approach using axially vascularized bone substitutes, which aims to enhance blood supply to the reconstructed tissue through a microvascular arteriovenous loop. The study seeks to evaluate the effectiveness of this technique in promoting successful healing and integration of the bone substitute in the craniofacial region. By addressing the challenges of vascularization in large defects, this approach could potentially reduce complications associated with traditional reconstruction methods.
Who should consider this trial
Good fit: Ideal candidates are middle-aged adults (18-65 years) with mandibular defects of 6 cm or more that are tumor-free.
Not a fit: Patients under 18 or over 65 years old, or those with uncontrolled chronic illnesses, may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to improved healing and functional outcomes for patients requiring jaw reconstruction.
How similar studies have performed: While similar techniques have shown promise in case reports, this specific application in the craniofacial region is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alexandria
- Faculty of Medicine, University of Alexandria — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmad M Eweida, MD, PhD
- Email: ahmad.eweida@alexmed.edu.eg
- Phone: 0049 017665232331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.