Adverse tissue reaction to a next-generation bioceramic sealer: a structured literature review and case report.

Background: Calcium silicate-based (bioceramic) sealers are widely used in endodontics due to their favorable biological properties and high clinical success rates. Although apical extrusion is generally considered well tolerated, cases of adverse tissue reactions have been reported. The aim of this study was to evaluate clinical outcomes associated with bioceramic sealer extrusion and to analyze potential biological complications. Materials and methods: A structured literature search was conducted in PubMed (MEDLINE), Scopus, and Web of Science databases for studies published between 2016 and 2026. The search strategy combined terms related to bioceramic sealers, root canal treatment, apical extrusion, and tissue reactions. Study selection followed a PRISMA-informed approach. Human clinical studies were included, and data on extrusion rates, clinical outcomes, and adverse reactions were extracted. In addition, a clinical case of persistent periapical inflammation associated with sealer extrusion is presented. Results: A total of 18 studies were included. Reported extrusion rates ranged from 11.8% to 60%, depending on the obturation technique. Overall success rates varied between 86% and 98% at follow-ups ranging from 12 months to 5 years. Most randomized clinical trials showed no significant association between sealer extrusion and treatment failure. However, rare complications, including foreign body reactions, neurological involvement, and persistent inflammatory lesions, were described, particularly in cases of prolonged tissue exposure or anatomical proximity to critical structures. Discussion: While bioceramic sealer extrusion is generally compatible with periapical healing, biological tolerance appears to be condition-dependent rather than absolute. Factors such as material volume, local microenvironment, and host response may influence outcomes. The presented case describes a persistent inflammatory lesion potentially associated with extruded material and requiring surgical intervention, emphasizing the importance of careful follow-up and clinical decision-making. Conclusions: Bioceramic sealer extrusion is usually well tolerated and not a primary determinant of treatment failure. However, persistent lesions beyond 6-9 months or recurrent clinical symptoms should prompt further investigation and possible intervention. Clinicians should adopt a structured monitoring approach and avoid underestimating atypical biological responses.