Davidson W M, Sheinis E M, Shepherd S R
Am J Orthod. 1982 Dec;82(6):502-7. doi: 10.1016/0002-9416(82)90319-0.
The widespread introduction of materials for direct bonding into practices and the numerous reports of a variety of toxic reactions to similar materials prompted a study of the toxicity of six adhesives in an animal model. Thirty-nine hamsters were employed to evaluate responses of skin, oral mucosa, and gingiva, sites of possible contamination by adhesives in clinical use. Animals were treated topically with separate components of adhesives. Adhesives were also allowed to polymerize on and remain in contact with tissues. Test sites were examined grossly and histologically and evaluated for toxic response. The monomer component of one adhesive consistently caused gross irritation and histologic inflammation in twelve animals (p less than 0.001) in which it was used. Other adhesives and components did not have this effect. This adhesive was withdrawn from the market and modified at about the same time these experiments were performed. Similar results have not been observed with the modified product. Clinicans should recognize the potential for reaction to adhesives and realize that products with a toxic potential can reach the market. They should be prepared to change adhesives should reactions to one be observed. They should further recognize that absence of reaction in any test system does not preclude reaction in clinical use.
直接粘结材料在临床实践中的广泛应用以及众多关于对类似材料产生各种毒性反应的报告,促使人们在动物模型中对六种粘合剂的毒性进行研究。选用39只仓鼠来评估皮肤、口腔黏膜和牙龈这些在临床使用中可能被粘合剂污染部位的反应。对动物局部使用粘合剂的各个成分。还让粘合剂在组织上聚合并保持与组织接触。对试验部位进行大体和组织学检查,并评估毒性反应。其中一种粘合剂的单体成分在使用该成分的12只动物中始终引起明显的刺激和组织学炎症(p小于0.001)。其他粘合剂及其成分没有这种作用。在进行这些实验的同时,这种粘合剂被撤出市场并进行了改良。改良后的产品未观察到类似结果。临床医生应认识到粘合剂有发生反应的可能性,并意识到具有潜在毒性的产品可能会进入市场。如果观察到对某种粘合剂有反应,他们应准备好更换粘合剂。他们还应进一步认识到,在任何测试系统中未出现反应并不排除在临床使用中发生反应的可能性。