Abstract
Objective The aim of this study was to evaluate the cytotoxic potential of a type of endodontic pin on L929 cell line according to the UNI EN ISO 10993/2009 rule. Methods L929 cells were used for the assays; extracts were prepared from three different-diameter endodontic pins, made of epoxy resin and fiberglass matrix and from Reference Materials (ZDEC, ZDBC, and HDP films). MTS assay was performed after 24 h, 48 h, and 72 h of exposure of L929 cells to pin and Reference Material extracts, 5% phenol solution, and control reagent. Cells cultured with different media containing extracts were monitored for up to 72 h and stained with haematoxylin/eosin. Results Pins of different diameters had no cytotoxic effects on L929 cells at 24 h, 48 h, and 72 h (all values >70%). Cells cultured in medium containing pin extracts grew without any differences compared to the control cells. Conclusion The endodontic pins tested showed no cytotoxic effects and did not induce changes in morphology for up to 72 h.
Highlights
Medical devices are designed for diagnostic, investigative, and treatment purposes and used in direct or indirect contact with the patient [1]. e Consensus Conference of the European Society for Biomaterials established that biomaterials are “non viable materials used in medical devices, intended to interact with biological systems” [2]
Part five gives specific guidelines for in vitro methods to evaluate the cytotoxicity of different types of materials. ese methods consist on the incubation of cell cultures with a medical device, in order to evaluate the in vitro biological response
Samples used were endodontic pins made of epoxy resin strengthened with fiberglass Richmond system (FiberSite post, Megadental Italia), available in three diameter sizes (2 mm, 4 mm, and 5 mm) matching up the mesiodistal diameters with the neck of all single-rooted teeth, in order to guarantee a perfect match between the abutment and root
Summary
Medical devices are designed for diagnostic, investigative, and treatment purposes and used in direct or indirect contact with the patient [1]. e Consensus Conference of the European Society for Biomaterials established that biomaterials are “non viable materials used in medical devices, intended to interact with biological systems” [2]. Marketing of any biomaterial or device, intended for human use or for a long-term contact, requires the assessment of the biological response [10]. For this purpose, the evaluation of biocompatibility is a crucial step to establish the safety of the material [11]. Cytotoxicity tests estimate the possible alterations in basic cellular functions [16] that can be evaluated by analyzing cellular metabolism, structure, and proliferation rate or vitality [17, 18] In this context, the UNI EN ISO 10993/2009 rule, BioMed Research International describes how to perform the biological evaluation of medical devices. E aim of this work was to assess the cytotoxic potential of three different-diameter endodontic pins, used in dentistry for restoring devitalized teeth, through an in vitro method, alternative to animal use. e L929 cell lines were used for this purpose, according to the UNI EN ISO 10993/ 2009 rule [19]
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