A Randomized, Parallel-Group (Autogenous EVPOME Versus AlloDerm Without Incorporation of Keratinocytes) Study in Subjects Reconstructed With Large Defect Mandibular Resection in Need of Vestibuloplasty for Dental Rehabilitation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Mandibular Injuries
- Sponsor
- Stephen E. Feinberg
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Percent Graft Contracture
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the safety and effectiveness of performing oral reconstructive surgeries using either AlloDerm, a product commonly used for this purpose, or AlloDerm that has been overlaid with the subject's oral mucosal cells and developed into a type of graft that is called an ex vivo produced oral mucosal equivalent, EVPOME.
Investigators
Stephen E. Feinberg
Professor & Associate Chair of Research
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Be an adult over 18 years of age
- •Have a free fibular graft placed more than six months ago that has been used for restoration of mandibular continuity.
- •Be in need of surgery to increase the vestibular fold of the grafted mandible for placement of a dental prosthesis to restore function
Exclusion Criteria
- •Any liver, kidney, heart, blood, metabolic or systemic disease which may make execution of the protocol of interpretation of the results difficult
- •A history of syphilis, HIV, Hepatitis B or Hepatitis C
- •Pregnancy or planning to become pregnant
- •Known or suspected allergy to bovine (cow) protein
- •Receiving radiation
- •Currently smoking or using tobacco products
- •Talking medication that can result in gingival enlargement (Cyclosporine, Dilantin, calcium channel blockers)
- •Allergy to any of the following antibiotics Gentamycin, Cefoxitin, Lincomycin, Polymyxin B, Vancomycin, cephalosporins, or clindamycin
- •Allergy to Polysorbate 20
Outcomes
Primary Outcomes
Percent Graft Contracture
Time Frame: 2-24 weeks
During surgery, after preparation of the recipient bed, the recipient bed and the graft will be measured for the maximum distance between non-resorbable sutures placed at the margins of the graft. Post-surgical measurements of the graft site will be taken at visits 5, 6, 7, and 8 and compared to original graft size to assess percentage of graft contracture.
Secondary Outcomes
- Degree of Epithelialized Tissue(4 weeks after surgery)
- Laser Doppler Flowmetry (LDF)(Visit 1 and 2 and 4 weeks after surgery)