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收到时及口内使用后的ClearCorrect®矫治器的化学分析与性能评估:对耐用性、美观性及患者安全性的影响

Chemical analysis and performance evaluation of ClearCorrect® aligners as received and after intraoral use: Implications for durability, aesthetics, and patient safety.

作者信息

Bouchema Tse, Saunier J, Mauriello J, Tfayli A, Savard B, Yagoubi N

机构信息

Matériaux et Santé, UFR de pharmacie, Université Paris Saclay, Orsay, France.

Matériaux et Santé, UFR de pharmacie, Université Paris Saclay, Orsay, France.

出版信息

Dent Mater. 2024 Dec;40(12):2135-2147. doi: 10.1016/j.dental.2024.10.003. Epub 2024 Oct 26.

Abstract

BACKGROUND

Orthodontic treatment with transparent aligners is popular with patients. Any alteration of the plastic material, as subjected to the oral environment, could influence the treatment's durability, the aligner's aesthetic appearance, and the patient's safety.

PURPOSE

This study concerns the physicochemical properties of ClearCorrect® aligners before and after intraoral use, focusing on transparency, surface topography, leachable, polymer glass transition temperature, and viscoelastic properties.

METHODS

Aligners were collected after two weeks of intraoral use. Unused samples were obtained from the manufacturers. Transparency was measured by UV-visible spectroscopy. Chemical modifications were studied using infrared and Raman spectroscopies. Thermal degradation, glass transition (T), and storage modulus (E') were characterized by thermal analysis (DSC, TGA, DMA). Surface morphology and roughness were studied thanks to SEM and AFM. Aligners were immersed in water-based solutions to identify and quantify organic leachable by HPLC chromatography and trace elements by atomic absorption spectroscopy.

RESULTS

ClearCorrect® aligners have a three-layer structure (outer PETG/inner PU layers). Slight chemical alterations occurred after aging. There was also no significant evolution in T and thermal degradation temperatures and only a minimal evolution of E'. Surface and transparency alterations occurred. A difference in organic compound and trace element release levels between new and used aligners was evidenced, suggesting an intraoral release during use.

SIGNIFICANCE

Intra-oral aging mainly impacts the aligner transparency and surface. The leachable study suggests significant ingestion of organic and non-organic compounds by the patient: investigations are needed to assess the impact of the long-term use of trays on patient health.

摘要

背景

使用透明矫治器进行正畸治疗很受患者欢迎。塑料材料在口腔环境中发生的任何变化都可能影响治疗的持久性、矫治器的美观外观以及患者的安全。

目的

本研究关注ClearCorrect®矫治器在口腔内使用前后的物理化学性质,重点是透明度、表面形貌、可溶出物、聚合物玻璃化转变温度和粘弹性。

方法

在口腔内使用两周后收集矫治器。未使用的样品从制造商处获得。通过紫外可见光谱法测量透明度。使用红外光谱和拉曼光谱研究化学变化。通过热分析(DSC、TGA、DMA)表征热降解、玻璃化转变(T)和储能模量(E')。借助扫描电子显微镜(SEM)和原子力显微镜(AFM)研究表面形态和粗糙度。将矫治器浸入水基溶液中,通过高效液相色谱法鉴定和定量有机可溶出物,并通过原子吸收光谱法测定微量元素。

结果

ClearCorrect®矫治器具有三层结构(外层PETG/内层PU层)。老化后发生了轻微的化学变化。T和热降解温度也没有显著变化,E'仅发生了最小程度的变化。表面和透明度发生了改变。新的和使用过的矫治器之间有机化合物和微量元素释放水平存在差异,这表明在使用过程中会在口腔内释放。

意义

口腔内老化主要影响矫治器的透明度和表面。可溶出物研究表明患者会大量摄入有机和无机化合物:需要进行调查以评估长期使用托盘对患者健康的影响。

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