Abstract
Background. The study aimed to compare the results of cytotoxicity and in vivo irritation and sensitization tests of a new antler-derived bone substitute with those of a bovine-derived xenograft.
Methods. This study included an in vitro cytotoxicity test based on ISO 10993‐5 standard. Additionally, in vivo irritation and sensitization tests were carried out according to ISO 10993-10 standard protocol.
Results. The cytotoxicity test showed a viability of 99.46±1.09% for the antler-derived bone substitute and 98.42±1.84% for the bovine xenograft (P=0.445). Furthermore, after 24 hours, no differences in morphological grade were found in both samples. The irritation test indicated a primary irritation index (PII) score of 0 for both the antler and bovine xenografts. Likewise, the sensitization test demonstrated a sensitization score of 0 for both the antler and bovine xenografts. All animals appeared clinically normal throughout the study in both in vivo tests, and all sites of the test extract and the reagent control seemed normal.
Conclusion. Both the antler-derived and bovine xenografts were found to be non-toxic, non-irritating, and non-sensitizing. Further studies should be conducted on other essential laboratory tests and animal and clinical studies.