Gasik Michael
School of Chemical Engineering, Aalto University Foundation, Finland.
Sci Technol Adv Mater. 2017 Jul 31;18(1):550-562. doi: 10.1080/14686996.2017.1348872. eCollection 2017.
One of the greatest challenges in the development of new medical products and devices remains in providing maximal patient safety, efficacy and suitability for the purpose. A 'good quality' of the tissue-implant interface is one of the most critical factors for the success of the implant integration. In this paper this challenge is being discussed from the point of view of basic stimuli combination to experimental testing. The focus is in particular on bacterial effects on tissue-implant interaction (for different materials). The demonstration of the experimental evaluation of the tissue-implant interface is for dental abutment with mucosal contact. This shows that testing of the interface quality could be the most relevant in controlled conditions, which mimic as possible the clinical applications, but consider variables being under the control of the evaluator.
新型医疗产品和器械研发面临的最大挑战之一,仍然是如何为患者提供最大程度的安全性、有效性以及与预期用途的适配性。组织-植入物界面的“优质”是植入物成功整合的最关键因素之一。本文从基本刺激组合到实验测试的角度探讨了这一挑战。重点尤其在于细菌对(不同材料的)组织-植入物相互作用的影响。对组织-植入物界面进行实验评估的示例是用于与黏膜接触的牙基台。这表明,在尽可能模拟临床应用的可控条件下,但要考虑变量处于评估者控制范围内时,对界面质量进行测试可能是最相关的。