Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Alveolar Bone Atrophy Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alveolar Bone Atrophy
• Alveolar Bone Loss
• Atrophy
• Bone Neoplasm, Benign
• Bone Neoplasms
• Disorders of Teeth and Jaw
• Jaw Fractures
• Maxillofacial Bone Defects
• Maxillofacial Bone Deformities
• Neoplasms
• Tooth Diseases

• NCT number: NCT02293031
• Study type: Interventional
• Source: NextGen Company Limited
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 2014
• Completion date: December 2017