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Mandibular Reconstruction With Axially Vascularised Bone Substitutes

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ClinicalTrials.gov Identifier: NCT04001842
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmad Mahmoud Eweida, University of Alexandria

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.

Condition or disease Intervention/treatment Phase
Mandibular Deficiency Other: Surgical reconstruction of the mandible using an axially vascularized bone construct Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mandibular Reconstruction Using Tissue Regeneration With Axially Vascularised Bone Substitutes
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2029
Estimated Study Completion Date : June 30, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Axially vascularized constructs
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
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)




Primary Outcome Measures :
  1. Radiological and histological evidence of bone formation in the mandibular defect [ Time Frame: 6-9 months ]
    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).


Secondary Outcome Measures :
  1. Dental rehabilitation [ Time Frame: 9 months ]
    Implantation of osteointegrated implants within the former defect



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001842


Contacts
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Contact: Ahmad M Eweida, MD, PhD 0049 017665232331 ahmad.eweida@alexmed.edu.eg

Locations
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Egypt
Faculty of Medicine, University of Alexandria Recruiting
Alexandria, Egypt
Contact: Ahmad M Eweida, MD, PhD    0049 017665232331    ahmad.eweida@alexmed.edu.eg   
Sponsors and Collaborators
University of Alexandria

Publications:

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Responsible Party: Ahmad Mahmoud Eweida, Lecturer of Surgery, University of Alexandria
ClinicalTrials.gov Identifier: NCT04001842    
Other Study ID Numbers: 040215
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmad Mahmoud Eweida, University of Alexandria:
Mandibular reconstruction
Mandibular regeneration
Regenerative Medicine
Tissue Engineering
Axial vascularization
Arterio-venous loop