Cytotoxicity and Mutagenicity of N2 Cement - Root Canal Filling Material

Background. Biocompatibility can be described as the ability of a material to function so as not to violate cell and tissue integrity when applied. Objectives. The contemporary requirements for biocompatible materials evaluated according to "evidence-based medicine" induced the authors to evaluate the mutagenicity and cytotoxicity of dental materials (medical devices) authorized for sale in the EU. The use of some endodontic materials is questioned by many specialists. Material and Methods. The Ames test was used to evaluate the mutagenicity of the most controversial endodontic cement, N2, according to the PN-EN ISO 10993-3: 2008 norm. The cytotoxicity of this material was evaluated according to the PN-EN ISO 10993-5: 2008 norm. Results: The tested material did not show any mutagenic activity, but it was severely cytotoxic in the concentration range of 0.78-200 mg/ml. Conclusions. In view of the broad availability of safe and effective alternatives, the use of paraformaldehyde-containing "aged" filling materials or root canal sealers is undoubtedly below the standard of care for endodontic treatment (Adv Clin Exp Med 2009, 18, 6, 615-621).