Bone Atrophy, Bone Cysts, Bone Deformity, Bone Fracture, Bone Loss, Tooth Loss
Conditions
Keywords
Gene-activated matrix, Bone substitute, Bone grafting, Dental implantation, gene therapy, plasmid DNA, VEGF gene, octacalcium phosphate
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid DNA encoding vascular endothelial growth factor (VEGF) for maxillofacial bone regeneration. The patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.
Detailed description
All participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. Bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. The safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.
Interventions
DEVICEGene-activated matrix (OCP + plasmid DNA with VEGF gene)
Bone grafting procedure with investigated medical device
Sponsors
Moscow State University of Medicine and Dentistry
Histograft Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge 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 trials (or administration of study products) within 3 months prior the study; * conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.); * pregnancy or lactation; * malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone tissue formation in the field of gene-activated bone substitute implantation | 6 months | To determine the quantity of newly formed bone tissue the following morphometric parameters will be measured on CT scan using special tools (ROI, region of interest, etc.): * average density (in HU); * size (length, width, height) and volume. All together both measurements allow to determine bone tissue formation as a value derived from the presence of newly formed bone tissue and its volume correspondence with the quantity of the material implanted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | 6 months | Evaluation of the Adverse Events and Serious Adverse Events frequency |
| Surgical failure rate | 6 months | Evaluation of the events frequency when the surgery was not completed due to the reasons related with gene-activated bone substitute |
Countries
Russia
Outcome results
None listed