Etilen Oksit Sterilizasyonunun PEEK Bazlı Dental İmplantın Kimyasal Yapısı Üzerine Etkisi

Year 2023, Volume: 15 Issue: 1, 139 - 150, 31.01.2023

Ogün Bozkaya

https://doi.org/10.29137/umagd.1148544

Abstract

Polietereterketon (PEEK), kemik ve kıkırdak replasmanı için uygun mekanik özelliklere sahip biyouyumlu bir polimerdir. Bu nedenle titanyum bazlı metallere alternatif olarak tıpta ve diş hekimliğinde birçok potaniyel kullanıma sahiptir. Tıbbi cihaz yönetmeliğine göre implante edilebilir cihazlar yüksek risk sınıfında olması nedeniyle yıkama, dezenfeksiyon ve sterilizasyon süreçlerinden geçirilirler. Etilen oksit (EtO) sterilizasyonu özellikle PEEK bazlı polimerik implantların sterilizasyonu için kullanılan en yaygın ve etkili yöntemlerden biridir. Bununla birlikte, değişken sterilizasyon koşulları, polimerik malzemenin kimyasal yapısında, mekanik özelliklerini ve ömrünü etkileyen birtakım değişikliklere neden olabilir. Bu çalışmanın amacı, belirli koşullar altında EtO ile sterilize edilen PEEK bazlı dental implantların kimyasal yapısının değişip değişmediğini araştırmaktır. Kimyasal karakterizasyon çalışmaları ISO 10993-18:2020 standardında polimerik malzemeler için önerilen fourier transform kızılötesi spektroskopisi (FT-IR), diferansiyel taramalı kalorimetri (DSC), termogravimetrik analiz (TGA), CHNS elementel analiz ve gaz kromatografi-kütle spektrometrisi (GC-MS) teknikleri kullanılarak yürütülmüştür. Karakterizasyon sonuçları, etilen oksit sterilizasyonundan sonra PEEK materyalin moleküler yapısında, kristalinitesinde ve elementel bileşiminde önemli bir değişiklik olmadığını ortaya koymuştur.

Keywords

PEEK, dental implant, medikal cihaz, etilen oksit, sterilizasyon, ISO 10993-18

Thanks

Sağladığı imkanlardan dolayı Kırıkkale Üniversitesi Bilimsel ve Teknolojik Araştırmalar Uygulama ve Araştırma Merkezi'ne (KUBTUAM) teşekkür ederim.

Effect of Ethylene Oxide Sterilization on the Chemical Structure of PEEK-based Dental Implant

Abstract

Polyetheretherketone (PEEK) is a biocompatible polymer with suitable mechanical properties for bone and cartilage replacement. Therefore, it has many potential uses in medicine and dentistry as an alternative to titanium-based metals. According to the medical device regulation, implantable devices are subjected to washing, disinfection and sterilization processes because they are in a high risk class. Ethylene oxide (EtO) sterilization is one of the most common and effective methods used especially for the sterilization of PEEK-based polymeric implants. However, variable sterilization conditions can cause a number of changes in the chemical structure of the polymeric material, affecting its mechanical properties and lifetime. The aim of this study is to investigate whether the chemical structure of PEEK-based dental implants sterilized with EtO under certain conditions changes. Chemical characterization studies were carried out using fourier transform infrared spectroscopy (FT-IR), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), CHNS elemental analysis and gas chromatography-mass spectrometry (GC-MS) techniques recommended for polymeric materials in the ISO 10993-18:2020 standard. The characterization results revealed that there was no significant change in the molecular structure, crystallinity and elemental composition of the PEEK material after ethylene oxide sterilization.

Keywords

PEEK, dental implant, medical device, ethylene oxide, sterilization, ISO 10993-18

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