Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Maxillofacial Bone Defects
- Sponsor
- NextGen Company Limited
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •obtained voluntary informed consent for participation in the clinical study;
- •congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.
Exclusion Criteria
- •not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
- •decompensated chronic visceral diseases;
- •clinically significant laboratory abnormalities;
- •HIV, HBV and HCV antibodies in serum;
- •alcohol consumption within 4 days prior the study;
- •history of drug addiction;
- •participation in other clinical studies (or administration of study products) within 3 months prior the study;
- •conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
- •malignancies including post-surgical period with chemo- and (or) radiation therapy);
- •vascular malformations;
Outcomes
Primary Outcomes
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
Time Frame: 60 days
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.
Secondary Outcomes
- Pain scores on the visual analog scale(60 days)
- Surgical failure rate(60 days)
- Edema scores on the 0-10 Numeric Rating Scale(60)
- Adverse Events(60 days)