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Toxicological assessment of additively manufactured methacrylates for medical devices in dentistry
Acta Biomaterialia ( IF 9.7 ) Pub Date : 2018-08-10 , DOI: 10.1016/j.actbio.2018.08.007
Frank Alifui-Segbaya , Jasper Bowman , Alan R. White , Sony Varma , Graham J. Lieschke , Roy George

The paucity of information on the biological risks of photopolymers in additive manufacturing or three-dimensional printing (3DP) is a major challenge for the uptake of the technology in the construction of medical devices in dentistry. In this paper, the biocompatibility of additively manufactured methacrylates are evaluated using the innovative zebrafish (Danio rerio) embryo model. Data obtained confirmed gradations of toxicity primarily influenced by ethanol treatment, exposure scenarios, and extraction vehicles. In direct exposure tests, zebrafish (AB/Tü) embryos cultured on materials with ultrapure water showed accelerated toxicological effects compared to counterparts in transparent E3 medium. Similarly, toxic extracts induced mostly acute responses rather than cumulative chronic as observed in direct exposure. FTIR spectra was used to quantify the double bond conversion of the materials and those with >60 % BisEMA displayed relatively low degree of conversion; however, they were safe in zebrafish bioassays after ethanol treatment in contrast to untreated methacrylates. The study affirms that biocompatibility was influenced primarily by the physico-chemical characteristics, which subsequently influenced their residual monomer content before and after ethanol treatment. Given the precautionary implications of the study, we propose a 3-tiered approach i.e. using approved materials, apposite manufacturing parameters and post-processing techniques that together guarantee optimal results for all medical devices.

Statement of significance

This study is timely and relevant since there is limited published literature that precisely describes the toxicological properties of additively manufactured methacrylates despite their increased popularity for medical devices. While it is generally accepted that the zebrafish excels as a model system for developmental toxicity, a further examination of its utility in this study using different protocols provides basis for its consideration and adoption at a crucial time when there is a lack of consensus regarding the most suited biological assessment methods for medical devices.



中文翻译:

牙科医疗器械用增材制造的甲基丙烯酸酯的毒理学评估

在增材制造或三维打印(3DP)中缺乏有关光敏聚合物生物风险的信息,对于在牙科医疗设备的构造中采用该技术是一项重大挑战。在本文中,使用创新的斑马鱼(Danio rerio)胚胎模型评估了添加制造的甲基丙烯酸酯的生物相容性。获得的数据证实了主要受乙醇处理,暴露情况和提取载体影响的毒性等级。在直接暴露测试中,斑马鱼与在透明E3培养基中培养的胚相比,在超纯水材料上培养的AB /Tü)胚显示出更快的毒理作用。同样,有毒提取物主要引起急性反应,而不是直接暴露所观察到的慢性累积反应。FTIR光谱用于量化材料的双键转化率,而BisEMA大于60%的材料则显示相对较低的转化率;然而,与未经处理的甲基丙烯酸酯相比,它们在乙醇处理后的斑马鱼生物测定中是安全的。该研究证实生物相容性主要受理化特性的影响,其理化特性随后影响了乙醇处理前后其残留单体含量。考虑到研究的预防意义,我们建议采用3层方法,即使用经过批准的材料,

重要声明

这项研究是及时且相关的,因为尽管有限的公开文献准确地描述了增材制造的甲基丙烯酸酯的毒理学性质,尽管它们在医疗器械中越来越受欢迎。虽然普遍认为斑马鱼可以作为发育毒性的模型系统,但在缺乏对大多数动物的共识的关键时刻,进一步研究其在本研究中使用不同方案的实用性为斑马鱼的考虑和采用提供了依据。适用于医疗设备的生物学评估方法。

更新日期:2018-08-10
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