Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in Moderate Periodontitis Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes of clinical attachment and periodontal probing pocket
研究概览
简要总结
Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).
详细描述
Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.
Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).
The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).
Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
- •Patients' age between 25 and 45 years old.
- •Systemically healthy patients.
- •No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.
排除标准
- •History of smoking.
- •Patients having previous adverse reaction to the products (or similar products) used in this study.
- •Grade C category that has rapid rate of progression.
- •Pregnant and lactating women.
研究组 & 干预措施
Group I (study group)
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
干预措施: lemongrass essential oil gel (Drug)
Group I (study group)
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
干预措施: Scaling and root planing (Procedure)
Group II (control group)
Scaling and root planing +intra-pocket application of placebo gel
干预措施: Placebo (Drug)
Group II (control group)
Scaling and root planing +intra-pocket application of placebo gel
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
Changes of clinical attachment and periodontal probing pocket
时间窗: at baseline and twelve weeks from intervention.
Millimeters (mm)
次要结局
- GCF concentration of MMP-8(at baseline, one week, and twelve weeks from intervention.)
研究者
Nadein El Sharif
A student of Master's degree
Alexandria University