Spots Global Cancer Trial Database for Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

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Trial Identification

Brief Title: Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Official Title: Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration

Study ID: NCT02293031

Conditions

Maxillofacial Bone Defects

Alveolar Bone Atrophy

Jaw Fractures

Maxillofacial Bone Deformities

Bone Neoplasm, Benign

Disorders of Teeth and Jaw

Interventions

Gene-activated matrix "Nucleostim"

Study Description

Brief Summary: The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

Detailed Description: All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.