Guidance on the assessment of biocompatibility of biomaterials: Fundamentals and testing considerations

Vinicius Rosa, Baiqing Yu, Nick Silikas, Nileshkumar Dubey, Gopu Sriram, Spiros Zinelis, Adriano F. Lima, Marco c. Bottino, Joao n. Ferreira, Gottfried Schmalz, D.C. Watts

Research output: Contribution to journalArticlepeer-review

Abstract

Background
Assessing the biocompatibility of materials is crucial for ensuring the safety and well-being of patients by preventing undesirable, toxic, immune, or allergic reactions, and ensuring that materials remain functional over time without triggering adverse reactions. To ensure a comprehensive assessment, planning tests that carefully consider the intended application and potential exposure scenarios for selecting relevant assays, cell types, and testing parameters is essential. Moreover, characterizing the composition and properties of biomaterials allows for a more accurate understanding of test outcomes and the identification of factors contributing to cytotoxicity. Precise reporting of methodology and results facilitates research reproducibility and understanding of the findings by the scientific community, regulatory agencies, healthcare providers, and the general public.

Aims
This article aims to provide an overview of the key concepts associated with evaluating the biocompatibility of biomaterials while also offering practical guidance on cellular principles, testing methodologies, and biological assays that can support in the planning, execution, and reporting of biocompatibility testing.
Original languageEnglish
Pages (from-to)1773-1785
Number of pages15
JournalDental Materials
Volume40
Issue number11
Early online date10 Aug 2024
DOIs
Publication statusE-pub ahead of print - 10 Aug 2024

Keywords

  • Bioactive materials
  • Biocompatibility and proliferation
  • Cell membrane damage, death and apoptosis
  • Dental pulp and periodontium
  • Nanoparticles
  • Restorative and regenerative materials
  • Tissue engineering and regeneration

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