OBJECTIVE Dental device is a very broad term that can be used to include any foreign material or product that is introduced in the host oral cavity to replace missing tissues. These devices are subjected to different environments which include dental hard tissues, tissue fluids, blood and saliva. All dental devices are continuously challenged microbiologically and a number of failures in clinical management are related to microbial colonization. Thus, the assessment of the antimicrobial properties of dental devices are extremely important. In this paper, a classification of dental devices is being proposed. This classification distinguishes the devices based on whether they are implantable or not, and also sub-classified based on their specific application and the substrate receiving the device. METHODS AND RESULTS A literature search was conducted to identify how dental devices have been tested with relation to the microbial strains used and whether the testing has been performed in isolation or reported with other relevant tests such as material characterization and biological activity. The results of the literature review were analyzed and recommendations for antimicrobial testing of dental devices are proposed. These recommendations include the need for the setting up of pre-testing parameters such as ageing and the details of the pre-testing sterilization procedures, as these may affect the material chemistry and the specification for antimicrobial testing to be done with specific single strains or polymicrobial that are native to the region where the device is located are also suggested. Testing can be undertaken in vitro, ex vivo and in vivo. Since the antimicrobial and biological activities influence/condition one another and the material chemistry may affect both the antimicrobial and biological testing this document also makes recommendations regarding biological assessment which can be carried out in isolation or integrated with the microbiological testing and also material testing methods including chemical and physical characterization of bulk, surface, eluted and degraded materials as well as physical characterization methods. SIGNIFICANCE The level of standardization of antimicrobial testing for the dental devices needs to be based on the device location and host interaction in order to increase the clinical applicability of the mentioned tests.

中文翻译：

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牙科设备抗菌测试的标准化。

目的牙科器械是一个非常宽泛的术语，可用于包括引入宿主口腔中以替代缺失组织的任何异物或产品。这些设备要经受不同的环境，包括牙齿硬组织，组织液，血液和唾液。所有牙科器械在微生物学上都面临挑战，临床管理中的许多失败都与微生物定植有关。因此，评估牙科器械的抗菌性能极为重要。在本文中，提出了一种牙科器械的分类。该分类基于设备是否可植入来区分设备，并且还根据设备的特定应用和接收设备的基板进行分类。方法和结果进行了文献检索，以确定牙科器械如何与所使用的微生物菌株相关联进行测试，以及该测试是否是单独进行的或是否已通过其他相关测试（例如材料表征和生物学活性）进行了报告。分析了文献综述的结果，并提出了对牙科器械进行抗菌测试的建议。这些建议包括需要设置诸如老化之类的预测试参数，以及预测试灭菌程序的细节，因为这些参数可能会影响材料的化学性质以及使用特定单一菌株或多菌种进行抗微生物测试的规格还建议使用设备所在区域的本地设置。测试可以在体外进行，离体和体内。由于抗微生物和生物活性会相互影响/相互影响，并且材料化学性质可能会影响抗微生物和生物检测，因此，本文档还提出了有关生物学评估的建议，这些建议可单独进行或与微生物检测结合进行，也可与材料检测方法结合使用，包括散装，表面，洗脱和降解物料的化学和物理表征以及物理表征方法。意义牙科设备抗菌测试的标准化水平需要基于设备的位置和宿主之间的相互作用，以提高上述测试的临床适用性。由于抗微生物和生物活性会相互影响/相互影响，并且材料化学性质可能会影响抗微生物和生物检测，因此，本文档还提出了有关生物学评估的建议，这些建议可单独进行或与微生物检测结合进行，也可与材料检测方法结合使用，包括散装，表面，洗脱和降解物料的化学和物理表征以及物理表征方法。意义牙科设备抗菌测试的标准化水平需要基于设备的位置和宿主之间的相互作用，以提高上述测试的临床适用性。由于抗微生物和生物活性会相互影响/相互影响，并且材料化学性质可能会影响抗微生物和生物检测，因此，本文档还提出了有关生物学评估的建议，这些建议可单独进行或与微生物检测结合进行，也可与材料检测方法结合使用，包括散装，表面，洗脱和降解物料的化学和物理表征以及物理表征方法。意义牙科设备抗菌测试的标准化水平需要基于设备的位置和宿主之间的相互作用，以提高上述测试的临床适用性。