DENLAS-10BM半导体激光对口腔软组织疾病治疗有效性和安全性研究  

Efficacy and safety of DENLAS-10BM semiconductor laser in the treatment of oral gingival hyperplasia

作　　者：李伯翰 邹士琦[1] 王霄[1] LI Bo-han;ZOU Shi-qi;WANG Xiao(Peking university the third hospitalResident BeiJing 100091,China)

机构地区：[1]北京大学第三医院口腔科,北京100083

出　　处：《中华老年口腔医学杂志》2020年第1期21-25,共5页Chinese Journal of Geriatric Dentistry

基　　金：北京大学第三医院院临床重点项目孵育项目A类(项目编号:BYSYZD2019009)。

摘　　要：目的:评价DENLAS-10BM半导体激光在口腔牙龈组织良性增生治疗中的有效性及安全性。方法:随机选取66名志愿者,其中实验组33例,对照组33例。实验组使用DENLAS-10BM半导体激光治疗仪;对照组使用Sirona Dental Systems GmbH激光治疗机。术后7天对激光切割效果、止血效果、一周后愈合有效率、安全性进行评价;并对实验方案中的主要、次要及安全性评价指标进行评估。结果:试验组DENTAL-10BM半导体激光治疗仪手术完成时间为3.09±2.11min,对照组为3.12±1.56min,无统计学差异(P>0.05)。试验组I级止血率为96.98%,对照组I级止血率为96.97%,无统计学差异(P>0.05);试验组和对照组的有效愈合率均为100%,无统计学差异。试验组与对照组有效差值的单侧区间95%可信区间下界>-10%,试验组非劣于对照组。安全性分析,试验组不良事件2例(6.06%),对照组不良事件3例(9.09%),无统计学差异(P>0.05)。结论:DENTAL-10BM半导体激光治疗仪在临床止血效果、愈合有效率及手术完成时间无统计学差异,两者的临床效果和安全性具有一致性。Objective:To evaluate the efficacy and safety of DENLAS-10BM semiconductor laser in the treatment of benign gingival hyperplasia.Methods:66 volunteers were randomly selected,including 33 in the experimental group and 33 in the control group.The experimental group was treated with DENLAS-10BM semiconductor laser therapy device,while the control group was treated with Sirona Dental Systems GmbH laser therapy machine.The effect of laser cutting,hemostasis,healing efficiency and safety were evaluated 7 days after operation.The main,secondary and safety evaluation indexes were evaluated.Results:The operation completion time of DENTAL-10BM semiconductor laser therapeutic instrument in the experimental group was 3.09(+2.11)minutes,while the control group was 3.12(+1.56)minutes,with P>0.05,with showing no statistical difference.The hemostasis rate of gradeⅠwas 96.98%in the experimental group and 96.97%in the control group,with P>0.05,showing no statistical difference;the effective healing rate of the experimental group and the control group were both 100%,without statistical difference.The lower bound of 95%confidence interval of one-sided interval of the effective difference between the experimental group and the control group was more than-10%,and the experimental group was not inferior to the control group.Safety analysis showed that there were 2 adverse events(6.06%)in the experimental group and 3 adverse events(9.09%)in the control group(P>0.05).Conclusion:There is was no significant difference in clinical hemostasis effect,healing efficiency and operation completion time between DENTAL-10 BM semiconductor laser therapeutic instrument and DENTAL-10 BM semiconductor laser therapeutic instrument.The clinical effect and safety of the two instruments are consistent.

关 键 词：半导体激光 口腔软组织疾病 安全性 有效性 

分 类 号：R782[医药卫生—口腔医学]