Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •pregnancy or lactation.
结局指标
主要结局
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation
时间窗: 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.
次要结局
- 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)