Objective: The purpose of the experiment was to determine the degree of biocompatibility of a sealer (RO, laboratory made product) dental material in terms of cytotoxicity and animal tests.
Materials And Methods: In the present study, the biological compatibility of eight experimental composite materials was examined by in vitro methods. The bio-composites used for the cytotoxicity test were placed into direct contact with normal human fibroblasts in a cell-culture dish. After fibroblast bioassay was performed, a duplicate sample of biomaterial was placed in each well, and then the fibroblasts were incubated for 48 hours at 37°C and 5% carbon dioxide. Local reactions after the implantation of the material regarding preclinical evaluation have been carried out within the Biobase Laboratory of the "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. The biocompatibility was studied using the tolerance test by the subcutaneous and intramuscular implantation of the cured specimens.
Results: The sealant C3 scored the highest value to the cell viability. The results of the present study showed that different dental materials had different effects on cells. The resin monomer TEGDMA, present in the sealer's composition, increased the amount of intracellular reactive oxygen species. Resin-based composites are cytotoxic before polymerization and immediately thereafter, whereas already set specimens cause almost no reaction. The test of tolerance showed that the composite materials do not contain any toxic, irritant substances or destructive ones for the living cells or tissues.
Conclusions: The tests with experimental composite materials revealed that they are not cytotoxic for the living cells, in all versions of the materials used. All the samples of composite materials have maintained their integrity during the experiment, allowing the testing together with the embedded cells, which proved good viability, so they are suitable for dentistry use.
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