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局部应用三果实凝胶对比派丽奥软膏治疗慢性牙周炎的随机双盲对照试验
A Randomized Double-blind Controlled Trial of Topical Triphala Gel Versus Periocline Ointment for the Treatment of Chronic Periodontitis
【摘要】 目的 评估三果实凝胶作为牙周袋内局部用药治疗中度至重度慢性牙周炎的临床疗效和安全性,并与派丽奥软膏进行比较。方法 采用随机、双盲、平行对照试验,60例慢性牙周炎患者按1∶1∶1随机分为三果实凝胶组、派丽奥软膏组和对照组,每组20例。所有患者均接受标准牙周基础治疗。基础治疗完成1周后,三果实凝胶组和派丽奥软膏组分别接受相应药物牙周袋内局部应用;对照组仅进行常规口腔卫生维护,不接受药物治疗。测量牙周袋深度(PD)、临床附着丧失(CAL)、菌斑指数(PI)、牙龈退缩(REC)、探诊出血指数(PBI)等指标,并记录不良反应发生情况。结果 治疗12周后,三果实凝胶组和派丽奥软膏组PD改善幅度均优于对照组(P<0.05),但两治疗组间差异无统计学意义(P>0.05);三果实凝胶组和派丽奥软膏组CAL改善幅度均优于对照组(P<0.05),但两治疗组间差异无统计学意义(P>0.05);三果实凝胶组和派丽奥软膏组PI改善幅度均优于对照组(P<0.05),但两治疗组间差异无统计学意义(P>0.05)。REC和PBI在三组间差异均无统计学意义(P>0.05)。三组均未出现严重不良反应。结论 三果实凝胶治疗慢性牙周炎安全有效,疗效与派丽奥软膏相当,为牙周辅助治疗提供新选择。
【Abstract】 Objective To evaluate the clinical efficacy and safety of triphala gel as adjunctive intrapocket therapy for moderate to severe chronic periodontitis compared with periocline ointment.Methods A randomized,double-blind,parallel-controlled trial involving 60 chronic periodontitis patients randomly allocated 1∶1∶1 to triphala gel,periocline ointment,and control groups (20 cases each).One week after the completion of basic treatment,the triphala gel group and the periocline ointment group received local application of corresponding drugs in periodontal pockets;the control group only received routine oral hygiene maintenance and did not receive medication treatment.Periodontal pocket depth (PD),clinical attachment loss (CAL),and plaque index (PI),gingival recession (REC),probing bleeding index (PBI) were measured,and record the occurrence of adverse reactions.Results After 12 weeks of treatment,the improvement of PD in the triphala gel group and the periocline ointment group were better than in the control group (P<0.05),but there was no significant difference between the two treatment groups (P>0.05).The improvement of CAL in the triphala gel group and the periocline ointment group were better than in the control group (P<0.05),but there was no significant difference between the two treatment groups (P>0.05).The improvement of PI in the triphala gel group and the periocline ointment group were better than in the control group (P<0.05),but there was no significant difference between the two treatment groups (P>0.05).There was no statistically significant difference in REC and PBI among the three groups (P>0.05).None of the three groups experienced serious adverse reactions.Conclusions Triphala gel demonstrates comparable efficacy to periocline ointment in treating chronic periodontitis,significantly improving periodontal parameters,provides a new option for adjunctive periodontal therapy.
【Key words】 Chronic periodontitis; Triphala; Topical medication; Randomized controlled trial; Periodontal pocket depth; Clinical attachment loss;
- 【文献出处】 药品评价 ,Drug Evaluation , 编辑部邮箱 ,2025年08期
- 【分类号】R781.42
- 【下载频次】9