Kux B J, Bacigalupo L M, Scriba A, Emmrich M, Jost-Brinkmann P-G
Institute of Dental, Oral and Maxillary Medicine, Department of Orthodontics, Dentofacial Orthopedics and Pedodontics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Aßmannshauser Str. 4-6, 14197, Berlin, Germany.
J Orofac Orthop. 2022 Jan;83(1):34-47. doi: 10.1007/s00056-021-00292-4. Epub 2021 Apr 14.
Main goal of the study was the identification and quantitative analysis of monomer elution from materials commonly used in fixed orthodontic therapy. Studies have shown severe health effects of monomers including cytotoxic, allergenic or mutagenic potential and endocrine changes. This in vitro study focusses primarily on five resins which are usually processed intraorally and remain in the oral cavity long-term.
We tested the elution of monomers from specimens (7.5 mm × 1.5 mm) immersed in artificial saliva at body temperature (37 °C) for 30 min to 5 weeks. The used method is in accordance with DIN EN ISO 10993-13. The five tested materials were BrackFix® (Voco GmbH, Cuxhaven, Germany), Triad®Gel (DeguDent GmbH, Hanau, Germany), and Transbond™ XT, LR and Plus (3M Unitek, Monrovia, CA, USA). All aliquots were analyzed using high performance liquid chromatography (HPLC). Data were statistically analyzed.
All five analyzed materials eluted substances over a period of 5 weeks. Identified substances included bisphenol A (BPA), triethylene glycol dimethacrylate (TEGDMA) and urethane dimethacrylate (UDMA). BPA eluted from Transbond™ Plus, XT, LR and BrackFix®. The cumulated mean values after 35 days ranged from 16.04 to 64.83 ppm, depending on the material. TEGDMA eluted with a mean of 688.61 ppm from Transbond™ LR. UDMA with a mean of 1682.00 ppm from Triad®Gel. For each material the highest concentrations of all these substances were found in the first elution period. Other substances that were not equivocally identified or of low concentration also eluted.
Using the described method, it is possible to qualitatively and quantitatively determine the in vitro elution of monomers from orthodontic materials. The concentrations of the substances identified were below the current maximum recommended intake. However, a cumulative effect and low-dose effects should be considered for both patients and dental professionals, especially for young patients. Measures to reduce exposure patients and practitioners are suggested.
本研究的主要目标是对固定正畸治疗中常用材料的单体洗脱进行鉴定和定量分析。研究表明，单体具有严重的健康影响，包括细胞毒性、致敏性或致突变性以及内分泌变化。这项体外研究主要聚焦于五种通常在口腔内加工并长期留存于口腔中的树脂。
我们测试了尺寸为7.5毫米×1.5毫米的样本在体温（37°C）的人工唾液中浸泡30分钟至5周后单体的洗脱情况。所采用的方法符合DIN EN ISO 10993 - 13标准。测试的五种材料分别是BrackFix®（德国库克斯港Voco GmbH公司）、Triad®Gel（德国哈瑙DeguDent GmbH公司）以及Transbond™ XT、LR和Plus（美国加利福尼亚州蒙罗维亚3M Unitek公司）。所有等分试样均采用高效液相色谱法（HPLC）进行分析。对数据进行了统计分析。
在5周的时间里，所有五种被分析材料均有物质洗脱。鉴定出的物质包括双酚A（BPA）、二甲基丙烯酸三乙二醇酯（TEGDMA）和二甲基丙烯酸聚氨酯（UDMA）。BPA从Transbond™ Plus、XT、LR和BrackFix®中洗脱。35天后的累积平均值在16.04至64.83 ppm之间，具体取决于材料。TEGDMA从Transbond™ LR中洗脱，平均含量为688.61 ppm。UDMA从Triad®Gel中洗脱，平均含量为1682.00 ppm。对于每种材料，所有这些物质的最高浓度均出现在首个洗脱期。其他未明确鉴定或浓度较低的物质也有洗脱。
使用所述方法，可以定性和定量地测定正畸材料中单体的体外洗脱情况。所鉴定物质的浓度低于当前推荐的最大摄入量。然而，对于患者和牙科专业人员，尤其是年轻患者，应考虑累积效应和低剂量效应。建议采取措施减少患者和从业者的接触。
