| Objective:preliminary throughPEI/Nano-SiO2/PEEK biological safety testing, to get thepossibility of its clinical application and provide a reliable experimental basis for thefuture clinical applications.Methods:Excellent biocompatibility is a prerequisite of materials used in clinical settings.According to the national pharmaceutical industry and international standards, MTT,acute toxicity test, oral mucosa stimulation experiment, and hemolytic test assay werechosen to evaluate the biocompatibility of PEEK composite for dental materials inthis paper.1. The leaching liquid was prepared with PEEK composite, according to differentmass fractions and then it was used to contact with cells. And the in vitro cytotoxicitytest was performed with tetrazolium salt colorimetric (MTT).Observation of cellviability and cell morphological changes, to evaluate the material is not the potentialcytotoxicity.2. Twenty healthy Wister rats were used as experimental animals. All of these ratswere divided into two groups at random. The test group was gavaged PEEKcomposite extracts, in accordance5mg/kg dose, once a day for seven consecutivedays, observed whether have the existence of toxic reactions such as diarrhea orconvulsions. Were killed after a week, take heart, liver, kidney and spleen organs,histological observation, whether the presence of inflammation or pathologicalchanges.3. Suture the sterilized and disinfected PEEK composite on the golden hamster’sbuccal mucosa, gutta-percha as a control. Visual observation for14days，whether the existence of mucosal congestion, erosion, ulceration, mucosal tissue histologydetect the presence of pathological changes.4.8ml blood of a healthy rabbit was gathered, then heparin sodium was added toform anticoagulant rabbit blood.8ml of anticoagulant rabbit blood was diluted with10ml physiological salt solution. Add10ml PEEK composite extracts and mixed with0.2ml anticoagulant rabbit blood in a glass tube. As positive and negative contrasts,the extracts was replaced with distilled water and physiological salt solution,respectively. Every tube was centrifuges for5min under2500r/min acceleration ofgravity after being incubated at37℃for60min, read every reagent of thesupernatant about the absorbance at545nm. Repeat3times and averaged. Thehemolysis rate calculated according to the formula: hemolysis ratio=(absorbancevalue of the experimental group–absorbance value of negative control group)/(positive control group values–negative control group value)×100％.Results:1Cytotoxicity test: cells of the PEEK composite extracts group grow well, noabnormal cells, no significant difference with the negative control group. Theconclusion is that no cytotoxicity of PEEK composite.2Acute systemic toxicity test: all the rats in the experimental group had nodeaths, toxic reactions, normal diet, a good mental state during the observation period.After the rats were injected with the extracts, their hearts, livers, kidneys and spleensorgan were observed by the naked eye and microscopes, and there is no abnormaltissue slices nor pathological changes.3mucous membrane irritation test: visual observation, PEEK composite groupmucous membrane contact area organizations are normal, no erythema, erosion, ulcersphenomenon; microscopy observation, the normal mucosal tissue, no significantdifference with the control group, and did not show any adverse reaction such asnecrosis or chronic inflammation. observed under a microscope the core is below4.Comprehensive naked eye and microscopic observation, PEEK composite have noirritation to the oral mucosa did not show any adverse reaction such as necrosis or chronic inflammation.4Hemolysis: PEEK composite group measured hemolysis rate of0.663%hemolysis rate of less than5%of the prescribed requirements, match the standards forthe pharmaceutical industry of the People’s Republic of China (YY), so PEEKcomposite not cause hemolytic reaction.Conclusion:PEEK composite has excellent biocompatibility, can be used as dental materialin clinical applications. |
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