In vitro studies
In vitro studies of FlexiOss® biomaterial were performed in Chair and Department of Biochemistry and Biotechnology od Medical University of Lublin. The results were published in scientific journals:
The tests proved that biomaterial is non-toxic against human fetal osteoblasts, which allowed the implantation of the biomaterial into the living organisms (in vivo study).
Studies on animals
Promising properties of FlexiOss® composite were confirmed in in vivo experiments. The biomaterial was subjected to preliminary pre-clinical evaluation on patients of Animal Surgery Clinic of Veterinary Medicine Faculty, University of Life Sciences in Lublin, Poland. FlexiOss® has been used for filling bone defects resulting from teeth extraction and for the treatment of oronasal fistulae in dogs and cats.
The composite was also used as a bone-substituting biomaterial for filling the defects in the tibial bones of laboratory rabbits.
The composite remained excellently fitted in the implantation site and its presence did not induce any inflammatory reactions. The results confirmed its biocompatibility with the surrounding bone tissue. Histological evaluation unambiguously showed that the process of bone tissue formation appeared in the implantation site, which was confirmed by the presence of bone cells and laminae, collagen fibres and Haversian canals.
Studies on humans
Clinical observations of the implanted FlexiOss® biomaterial were conducted in patients at the Department of Trauma Surgery and Emergency Medicine of the Medical University of Lublin and New-Dent Stomatological Centre in Lublin, Poland.
Among others, FlexiOss® was used in the treatment of comminuted fractures with bone tissue defects in long bones and in the filling of bone pockets for bone tissue regeneration, augmentation of defects after teeth extractions and after cystotomy during tooth root resection, and augmentation.
FlexiOss® showed positive effects, underwent the remodelling with the formation of bone tissue and did not evoke any side effects such as the formation of bone cysts or the appearance of allergic reactions.
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