EVPOME Versus AlloDerm in Subjects Reconstructed With Large Defect Mandibular Resection

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

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.

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