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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Gene-activated matrix "Nucleostim" is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug "Neovasculgen"®.
Burnasyan Federal Medical Biophysical Center
Moscow, Russia
Moscow State University of Medicine and Dentistry
Moscow, Russia
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.) The morphometric parameters of bone regenerate include: * average density (in HU); * size (length, width, height) and volume.
Time frame: 60 days
Pain scores on the visual analog scale
Time frame: 60 days
Surgical failure rate
Time frame: 60 days
Adverse Events
Time frame: 60 days
Edema scores on the 0-10 Numeric Rating Scale
Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.
Time frame: 60
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