Ponce-Bravo Santa, Ledesma-Montes Constantino, Martínez-Rivera José-Luis, Garcés-Ortíz Maricela
Oral Pathology Laboratory. División de Estudios de Posgrado e Investigación. Facultad de Odontología, Universidad Nacional Autónoma de México. México, Distrito Federal. MÉXICO.
J Clin Exp Dent. 2015 Apr 1;7(2):e289-92. doi: 10.4317/jced.52201. eCollection 2015 Apr.
International rules must be followed for testing biosecurity in dental materials. A new brand of restorative material appeared in the market and regulations indicated that it should be tested for toxicity.
The aim of this study was to determine the 90-day sub chronic toxicity of one triethylene glycol dimethacrylate containing composite (MEDENTAL Light-Cure Composite™) orally administered to rats according to Organization for Economic Co-Operation and Development no. 48 guidelines and the requirements specified in the ISO 10993-11.
Wistar rats ate the polymerized composite during 90 days and were observed to determine changes in their behavior, eye and skin signs and other attitudes such as aggressiveness, posture, walking and response to handling. After 90 days were sacrificed to ascertain blood alterations, we did special hematological tests and assessed microscopic slides from 33 different organs.
We recorded no significant changes in clinical behavior of the animals. Microscopic review of the H&E stained slides obtained from the analyzed organs showed no abnormal inflammatory or cytological changes and all hematological special tests were within normal limits.
Results of this study show that under our experimental conditions the MEDENTAL Light-Cure Composite™ does not produce inflammatory or cytological changes suggestive of toxicity. Key words:Dental materials, composite resin, toxicity, inflammation, TEGDMA.
在对牙科材料进行生物安全性测试时必须遵循国际规则。市场上出现了一种新型修复材料,法规规定应对其进行毒性测试。
本研究的目的是根据经济合作与发展组织第48号指南以及ISO 10993-11规定的要求,确定口服给予大鼠的一种含二缩三乙二醇二甲基丙烯酸酯的复合材料(MEDENTAL光固化复合材料™)的90天亚慢性毒性。
Wistar大鼠连续90天食用聚合后的复合材料,并对其行为、眼部和皮肤体征以及其他行为表现(如攻击性、姿势、行走和对处理的反应)进行观察。90天后将大鼠处死以确定血液变化,我们进行了特殊的血液学检测,并对33个不同器官的显微切片进行了评估。
我们记录到动物的临床行为没有显著变化。对从分析器官获得的苏木精和伊红染色切片进行显微镜检查,未发现异常炎症或细胞学变化,所有血液学特殊检测结果均在正常范围内。
本研究结果表明,在我们的实验条件下,MEDENTAL光固化复合材料™不会产生提示毒性的炎症或细胞学变化。关键词:牙科材料、复合树脂、毒性、炎症、TEGDMA