Gene-activated Bone Substitute for Maxillofacial Bone Regeneration (NCT03076138) | Clinical Trial Compass
CompletedNot Applicable
Gene-activated Bone Substitute for Maxillofacial Bone Regeneration
Russia20 participantsStarted 2017-03-06
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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.
What they're measuring
1
Bone tissue formation in the field of gene-activated bone substitute implantation