摘要
目的:评价Denlase-980/7半导体激光在口腔软组织切割治疗中的有效性及安全性。方法:本临床试验采用随机对照的原则,选取132名志愿者,其中试验组66例,对照组66例。试验组使用Denlase-980/7半导体激光治疗仪;对照组使用Sirona Dental Systems GmbH激光治疗机。选取手术种类:试验组66例,其中牙龈组织切割49例,口腔粘膜切割17例。对照组66例,其中牙龈组织切割43例,口腔粘膜切割23例。通过对激光切割效果、止血效果、一周后愈合有效率、安全性进行评价;并对试验方案中的主要、次要及安全性评价指标进行评估。结果:试验组Denlase-980/7半导体激光治疗仪手术完成时间为11.59±8.82min,对照组为11.64±9.27min,P>0.05,无统计学差异。试验组I级止血42例,对照组I级止血43例,P>0.05,无统计学差异;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%可信区间下限-3.63%>-10%,试验组非劣于对照组。安全性分析,试验组和对照组均未发生不良事件。结论:Denlase-980/7半导体激光治疗仪在口腔软组织外科手术治疗中,与国外半导体激光相比,两者的临床效果和安全性无统计学差异,具有一致性。为患者及术者带来极大的便利,具有广泛的应用前景。
Objective:To evaluate the effectiveness and safety of Denlase-980/7 diode laser in the treatment of oral soft tissue mass.Methods:Our study was following the principle of randomized and parallel control.Total 132 volunteers were randomly selected in this study,including 66 in the experimental group and 66 in the control group.The experimental group was treated with Denlase-980/7 diode laser and the control group was treated with Sirona Dental Systems GmbH laser.Gingival tissue group was 49 cases in the experimental group and 43 cases in the control group.Oral mucosa tissue group was cut in 17 cases in the experimental group and 23 cases in the control group.The effects of laser cutting,hemostasis,healing efficiency and safety after one week were evaluated.Results:The operation time of Denlase-980/7 diode laser in the experimental group was 11.59(+8.82)minutes,while that of the control group was 11.64(+9.27)minutes,P>0.05,with no statistical difference.There was no statistical difference in 42 cases of grade I hemostasis in the experimental group and 43 cases of grade I hemostasis in the control group(P>0.05).The effective healing rates of the experimental group and the control group were 100%,with no statistical difference.The lower limit of 95%confidence interval of unilateral interval of the effective difference between the experimental group and the control group was-3.63%>10%.The experimental group was not inferior to the control group.Safety analysis showed no adverse events occurred in the experimental group and the control group.Conclusion:Denlase-980/7 semiconductor laser therapeutic instrument has no statistical difference in clinical hemostasis effect,healing efficiency and operation completion time,and the clinical effect and safety of the two instruments are consistent.Our study demonstrated that the Denlase-980/7 diode laser will bring great convenience to the patients and operators and showed comprehensive application prospect.
作者
李伯翰
邹士琦
王霄
LI Bo-han;ZOU Shi-qi;WANG Xiao(Department of stomatology,Peking University the Third Hospital,Beijing 100083,China)
出处
《口腔颌面修复学杂志》
2020年第1期17-22,共6页
Chinese Journal of Prosthodontics
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)。
