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整体式氧化锆牙科修复体的老化:一项为期5年的前瞻性临床研究方案,采用电子分析。

Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using e analyses.

作者信息

Koenig Vinciane, Wulfman Claudine P, Derbanne Mathieu A, Dupont Nathalie M, Le Goff Stéphane O, Tang Mie-Leng, Seidel Laurence, Dewael Thibaut Y, Vanheusden Alain J, Mainjot Amélie K

机构信息

Dental Biomaterials Research Unit (d-BRU) and Department of Fixed Prosthodontics, Institute of Dentistry, University of Liège (ULg) and University of Liège Hospital (CHU), 45 Quai G. Kurth, Liège, 4020, Belgium.

Unité de Recherches en Biomatériaux Innovants et Interfaces (URB2i) - EA442, Faculté de Chirurgie Dentaire, Université Paris Descartes, Sorbonne Paris-Cité, Montrouge, 92120, France.

出版信息

Contemp Clin Trials Commun. 2016 Jun 17;4:25-32. doi: 10.1016/j.conctc.2016.06.001. eCollection 2016 Dec 15.

Abstract

BACKGROUND

Recent introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) monolithic zirconia dental prostheses raises the issue of material low thermal degradation (LTD), a well-known problem with zirconia hip prostheses. This phenomenon could be accentuated by masticatory mechanical stress. Until now zirconia LTD process has only been studied . This work introduces an original protocol to evaluate LTD process of monolithic zirconia prostheses in the oral environment and to study their general clinical behavior, notably in terms of wear.

METHODS/DESIGN: 101 posterior monolithic zirconia tooth elements (molars and premolars) are included in a 5-year prospective clinical trial. On each element, several areas between 1 and 2 mm (6 on molars, 4 on premolars) are determined on restoration surface: areas submitted or non-submitted to mastication mechanical stress, glazed or non-glazed. Before prosthesis placement, analyses regarding LTD and wear are performed using Raman spectroscopy, SEM imagery and 3D laser profilometry. After placement, restorations are clinically evaluated following criteria of the World Dental Federation (FDI), complemented by the analysis of fracture clinical risk factors. Two independent examiners perform the evaluations. Clinical evaluation and analyses are carried out after 6 months and then each year for up to 5 years.

DISCUSSION

For clinicians and patients, the results of this trial will justify the use of monolithic zirconia restorations in dental practice. For researchers, the originality of a clinical study including analyses of material aging will provide important data regarding zirconia properties.Trial registration: ClinicalTrials.gov Identifier: NCT02150226.

摘要

背景

计算机辅助设计/计算机辅助制造(CAD/CAM)整体式氧化锆牙科修复体的近期引入引发了材料低热降解(LTD)问题,这是氧化锆髋关节假体中一个众所周知的问题。咀嚼机械应力可能会加剧这种现象。到目前为止,仅对氧化锆LTD过程进行了研究。这项工作引入了一种原始方案,以评估口腔环境中整体式氧化锆修复体的LTD过程,并研究其一般临床行为,特别是在磨损方面。

方法/设计:101个后牙整体式氧化锆牙齿元件(磨牙和前磨牙)被纳入一项为期5年的前瞻性临床试验。在每个元件上,在修复表面确定1至2毫米之间的几个区域(磨牙上6个,前磨牙上4个):承受或未承受咀嚼机械应力的区域、有釉或无釉区域。在假体植入前,使用拉曼光谱、扫描电子显微镜成像和三维激光轮廓测量法对LTD和磨损进行分析。植入后,根据世界牙科联盟(FDI)的标准对修复体进行临床评估,并辅以骨折临床风险因素分析。由两名独立的检查者进行评估。在6个月后进行临床评估和分析,然后每年进行一次,直至5年。

讨论

对于临床医生和患者来说,该试验的结果将证明在牙科实践中使用整体式氧化锆修复体的合理性。对于研究人员来说,一项包括材料老化分析的临床研究的创新性将提供有关氧化锆性能的重要数据。试验注册:ClinicalTrials.gov标识符:NCT02150226。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c794/5935864/ce7c8d2e1d00/gr1.jpg

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