Mandibular Reconstruction With Axially Vascularised Bone Substitutes

NCT04001842 | Recruiting

• 1 other identifier: 040215
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Deficiency

Keywords

Mandibular reconstruction; Mandibular regeneration; Regenerative Medicine; Tissue Engineering; Axial vascularization; Arterio-venous loop

Outcome Measures

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).

  6-9 months

Secondary Outcomes (1)

• Dental rehabilitation

  9 months

Study Arms (1)

Axially vascularized constructs

EXPERIMENTAL

Reconstructing a mandibular defect using an axially vascularized bone substitute using the arteriovenous loop (AVL)

Other: Surgical reconstruction of the mandible using an axially vascularized bone construct

Interventions

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

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)

Axially vascularized constructs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine, University of Alexandria

Alexandria, Egypt

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmad M Eweida, MD, PhD

CONTACT

0049 017665232331; ahmad.eweida@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Surgery

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2019
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)