Cytotoxicity and Genotoxicity of Newly Formulated Bioceramic Sealers: An In Vitro Study.

INTRODUCTION: Bioceramic sealers are used for their favorable biocompatibility, yet concerns remain regarding cytotoxicity and genotoxicity when extruded. Recently introduced sealers, C-Root SP (CSP) and BC Sealer Ion Plus (BCIP), incorporate formulations that enhance bioactivity. This study aimed to evaluate and compare the cytotoxicity and genotoxicity of CSP, BCIP, and EndoSequence BC Sealer (ESBC) in human periodontal ligament (hPDL) fibroblasts. METHODS: HPDL fibroblasts were exposed to full strength and 1:10 dilution media conditioned with ESBC, BCIP, and CSP. Cytotoxicity was assessed using CellTox™ Green and CellTiter-Glo® assays. Genotoxicity was evaluated via immunofluorescence staining for γH2AX and 53BP1. Statistical analysis was performed using one-way or two-way ANOVA with statistical significance P < 0.05. RESULTS: At full concentration, CSP was significantly more cytotoxic than ESBC or BCIP (P < .05), with all three falling below the 70% ISO viability threshold. At 1:10 dilution, only CSP maintained cell viability comparable to untreated controls. No changes in cytotoxicity were observed for the 3 materials at full-strengths at 24, 48, and 72 hours (P > .05); however, at 1:10 dilution, ESBC cytoxicity was higher than CSP and BCIP at 72 hours . Immunofluorescence revealed significantly higher genotoxicity with full-strength ESBC compared to CSP and BCIP (P < .05); no significant genotoxic differences were observed at 1:10 dilution (P > .05). CONCLUSIONS: These findings highlight the importance of concentration-dependent effects when selecting bioceramic sealers for clinical use.