CAJ | 학술논문

目的：观察和评价天然煅烧骨修复材料对颌骨缺损修复的疗效及其安全性。方法：采用随机、双盲、平行、阳性（Bio-Oss）对照、多中心临床试验设计。主要评价指标为缺损部位影像学检查，次要疗效评价指标为手术伤口愈合情况、排异反应、骨代谢变化、骨感染征象，以不良反应发生率作为安全性评价指标。结果：本临床试验共入组280例受试者，完成试验269例，脱落率3．93％。主要有效性评价指标影像学检查有效率：试验组93．70％、对照组93．08％。次要疗效评价2组材料植入后伤口愈合时间均小于7 d，2组均无排异反应、无骨代谢变化、无骨感染征象。不良事件发生率试验组0．72％、对照组2．14％。结论：天然煅烧骨修复材料用于拔牙后颌骨缺损修复的疗效和安全性非劣效于 Bio-Oss。
목적：관찰화평개천연단소골수복재료대합골결손수복적료효급기안전성。방법：채용수궤、쌍맹、평행、양성（Bio-Oss）대조、다중심림상시험설계。주요평개지표위결손부위영상학검사，차요료효평개지표위수술상구유합정황、배이반응、골대사변화、골감염정상，이불량반응발생솔작위안전성평개지표。결과：본림상시험공입조280례수시자，완성시험269례，탈락솔3．93％。주요유효성평개지표영상학검사유효솔：시험조93．70％、대조조93．08％。차요료효평개2조재료식입후상구유합시간균소우7 d，2조균무배이반응、무골대사변화、무골감염정상。불량사건발생솔시험조0．72％、대조조2．14％。결론：천연단소골수복재료용우발아후합골결손수복적료효화안전성비렬효우 Bio-Oss。
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.