A multi-center clinical trial of natural calcined bone repair material in repairing bone defect after tooth extraction
10.3969/j.issn.1001-3733.2015.01.018
- VernacularTitle:天然煅烧骨修复材料用于拔牙后颌骨缺损修复的多中心临床研究
- Author:
Ni CUI
;
Ruifeng QIN
;
Rui HOU
;
Yuxiang DING
;
Linlin ZHANG
;
Xiaojuan WANG
;
Kaijin HU
- Publication Type:Journal Article
- Keywords:
Natural calcined bone repair materials;
Tooth extraction;
Repair ofjaw bone defect;
Clinical trial
- From:
Journal of Practical Stomatology
2015;(1):81-84
- CountryChina
- Language:Chinese
-
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.
