The Journey of Endodontic Biomaterials: Navigating Scientific, Clinical, Patient, and Regulatory Demands.

Abstract

Introduction: The development of endodontic biomaterials requires balancing scientific performance, clinical practicality, patient expectations, and regulatory requirements. This review synthesizes these perspectives to map current strengths, limitations, and translational pathways for materials used in vital pulp therapy, root repair, and root canal filling, as well as regenerative endodontics.

Methods: Narrative literature synthesis integrating recent primary studies, systematic reviews, regulatory standards and normative documents, alongside clinical and market observations, to derive a holistic framework for endodontic biomaterials.

Results: Scientific priorities favor biocompatibility and bioactivity and regenerative potential, whereas clinicians prioritize ease of handling, predictable performance, and cost-effectiveness. Patients primarily value symptom relief, function, and aesthetics. Regulatory frameworks impose safety and quality requirements through biological validation and mechanical testing. Developments over the past decades demonstrate that hydraulic calcium silicate cements have achieved successful clinical translation by reconciling, in particular, biocompatibility with clinical performance. Biomaterials used in regenerative endodontic procedures likewise show promising clinical outcomes; however, histological evidence frequently indicates reparative tissue formation rather than true pulp-dentin complex regeneration. Emerging directions in both fields, including premixed and fast-setting formulations, smart materials or drug-device combinations, and customized scaffolds for endodontic tissue engineering, hold considerable promise but require clinically relevant testing and demonstration of superiority over current state-of-the-art applications.

Conclusions: Future innovation in endodontic biomaterials will depend on integrating scientific rigor, clinical feasibility, patient demand, and regulatory strategy from early development to ensure safe, adoptable, and clinically meaningful advances in care.