title: Cytotoxicity Evaluation and Crystallochemical Analysis of a Novel and Commercially Available Bone Substitute Material.
abstract: BACKGROUND
  Alloplastic biomaterials are an alternative for autologous transplants and xenografts in oral surgery and dental implantology. These non-immunogenic and resorbable materials are becoming the basis for complete and predictable guided bone regeneration in many cases. The chemical composition of a great majority of them is based on calcium phosphate salts. In vivo performance is often variable.
  
  
  OBJECTIVE
  The objective was to evaluate the biological and chemical properties of an experimental bone substitute material.
  
  
  METHODS
  The present research focuses on the cytotoxicity comparison and physiochemical characterization of two biomaterials: a novel chitosan/tricalcium phosphate/alginate composite (CH/TCP/Ag) and a commercially available synthetic bone graft made of HA (60%) and βTCP (40%) (HA/TCP). The materials were evaluated according to PN-EN ISO 10993 Biological evaluation of medical devices i.e. cytotoxicity on mouse fibroblasts (L929) and, in addition, tests on human osteoblasts (hFOB1.19) and human osteosarcoma (MG-63) were conducted. The crystallochemical analysis was performed using the X-ray powder diffraction method. The Bruker-AXS D8 Advance diffractometer (Karlsruhe, Germany) was used to collect diffractograms.
  
  
  RESULTS
  The tested materials showed a close resemblance in chemical composition and a considerable differentiation in cytotoxic response.
  
  
  CONCLUSIONS
  The novel composite demonstrated a high degree of cytocompatibility, which is promising in future clinical trials.
authors.affiliation: Medical Devices, National Medicines Institute, Warszawa, Poland.
authors.forename: Witold
authors.initials: W
authors.lastname: Bojar
authors.affiliation: Biomedical Engineering Laboratory, Faculty of Chemical and Process Engineering, Warsaw University of Technology, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Ciach
authors.affiliation: Biomedical Engineering Laboratory, Faculty of Chemical and Process Engineering, Warsaw University of Technology, Poland.
authors.forename: Martyna
authors.initials: M
authors.lastname: Kucharska
authors.affiliation: Medical Devices, National Medicines Institute, Warszawa, Poland; National Center for Nuclear Research, Warszawa, Poland.
authors.forename: Jan
authors.initials: J
authors.lastname: Maurin
authors.affiliation: Biochemistry and Biopharmaceuticals Department, National Medicines Institute, Warszawa, Poland.
authors.forename: Beata M
authors.initials: BM
authors.lastname: Gruber
authors.affiliation: Biochemistry and Biopharmaceuticals Department, National Medicines Institute, Warszawa, Poland.
authors.forename: Jolanta
authors.initials: J
authors.lastname: Krzysztoń-Russjan
authors.affiliation: Biochemistry and Biopharmaceuticals Department, National Medicines Institute, Warszawa, Poland.
authors.forename: Irena
authors.initials: I
authors.lastname: Bubko
authors.affiliation: Biochemistry and Biopharmaceuticals Department, National Medicines Institute, Warszawa, Poland.
authors.forename: Elżbieta L
authors.initials: EL
authors.lastname: Anuszewska
mesh_terms: D000818:Animals; D001859:Bone Neoplasms / Q000473:pathology*; D018786:Bone Substitutes / Q000737:chemistry / Q000633:toxicity*; D045744:Cell Line, Tumor; D002470:Cell Survival / Q000187:drug effects; D003460:Crystallization; D018360:Crystallography, X-Ray; D005347:Fibroblasts / Q000187:drug effects* / Q000473:pathology; D006801:Humans; D051379:Mice; D010006:Osteoblasts / Q000187:drug effects* / Q000473:pathology; D012516:Osteosarcoma / Q000473:pathology*; D033362:Powder Diffraction; D018570:Risk Assessment; D013997:Time Factors
chemical_list: D018786:Bone Substitutes