A multi-center clinical trial of natural calcined bone repair material in repairing bone defect after tooth extraction / 实用口腔医学杂志

ABSTRACT

Objective:To study the efficacy and safety of natural calcined bone repair material(NCBM)in repairing bone defect af-ter tooth extraction.Methods:A randemized,double-blinded,parallel,positive control(Bio-Oss)and multi-center clinical trial was employed.Imaging examination was used as the main efficacy evaluation index,surgical wound healing,rejection reaction,bone me-tabolic changes,bone infection signs were the subordinate efficacy evaluation indexes,the incidence of adverse reactions was observed for safety evaluation.Results:280 cases were included,269 cases completed the trial.In NCBMand Bio-Oss group the effective rate of imaging examination was 93.08% and 93.70%(P >0.05)respectively.The wound healing time of the 2 groups was less than 7 days,no rejection reaction,bone metabolic change and bone infection sign were observed.The incidence of adverse events in NCBM and the Bio-Oss group was 0.72% and 2.14%(P >0.05)respectively.Conclusion:The efficacy and safety between natural cal-cined bone repair material is not inferior to Bio-Oss in repairing bone defect after tooth extraction.