The Denture Adhesive Of Macromolecular Polymer Hydrogel Biological Safety Evaluation

Objectives:On a cytotoxicity study of The denture adhesive of macromolecular polymer hydrogel by MTT assay, oral mucous membrane irritation test and acute systemic toxicity test, to provide a basis on the biology for its clinical application. Methods:Select the mouse fibroblasts(L929), golden hamsters and ICR mice as the object to studied.In the test 1, The experimental materials extracts and L929 cells were cultured in vitro exposure, using inverted phase contrast microscope to observe cell morphology, Using MTT assay, by measuring the absorbance of the cell(A), to quantify cytotoxicity, thereby calculate the relative growth rate(GRG), to evaluate the cytotoxicity of the denture adhesive. In the test 2, preparation of the gutta percha to a diameter of 5mm, a thickness of 0.5 ~ 0.7mm wafer,put The experimental materials on it, stitched in gold hamster’s cheek pouch at the lower,after 14 days, observation the cheek pouch gross morphology and resection, get on pathological analysis. In the test3,by gavage and intraperitoneal injection two ways, ICR mice were injected on The experimental materials extract,after two weeks, dissection the mice and removal of vital organs was observed, get on pathological analysis. Results:1.In the MTT test,The No. 1 experimental materials cytotoxicity was grade 3,is moderately toxic. The No. 2 experimental materials cytotoxicity was grade 3,is moderately toxic,too.2.In the Oral mucous membrane irritation test, in the eye view, with the experimental materials in contact with cheek pouches and surrounding tissues were normal. But after tissue resection HE staining, microscopic observation revealed that the staining of certain tissues appear abnormal like Inflammatory cell infiltration and basal cell vacuolar degeneration.3.In the acute systemic toxicity test, in the eye view, ICR mice’s vital organs were normal, but after tissue resection HE staining, microscopic observation revealed that the heart, liver, kidney, stomach and other organs are different degrees of abnormalities except spleen. Conclusions:The MTT assay, oral mucous membrane irritation test and acute systemic toxicity test together affirm the biosafety substandard performance of the denture adhesive of macromolecular polymer hydrogel, unfit used in clinical practice.