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临床试验/NCT05241509
NCT05241509已完成4 期

Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis: A Randomized Controlled Clinical Trial

Souzy Kamal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in clinical attachment loss

研究概览

简要总结

Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.

Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.
  • patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months

排除标准

  • history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women

研究组 & 干预措施

Group I (test)

Experimental

included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.

干预措施: Cymbopogon citratus (lemongrass) oil gel (Drug)

Group II (control)

Placebo Comparator

included twenty treated with SRP and intrapocket application of placebo gel.

干预措施: Cymbopogon citratus (lemongrass) oil gel (Drug)

结局指标

主要结局

Change in clinical attachment loss

时间窗: baseline and after 12 weeks

the distance between the CEJ and depth of probing

Change in Matrix metalloproteinase-8 level

时间窗: baseline and after 12 weeks

Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample

Change in periodontal pocket depth

时间窗: baseline and after 12 weeks

the distance between the gingival margin and depth of probing

次要结局

未报告次要终点

研究者

发起方
Souzy Kamal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Souzy Kamal

lecturer of oral medicine, periodontology, oral diagnosis and radiology

Alexandria University

研究点 (1)

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