Evaluation of the Efficacy of Topically Applied Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis; Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
研究概览
简要总结
This study was conducted to assess the benefit of locally delivered melatonin gel as adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.
详细描述
Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month. The periodontal parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF) samples were collected and a quantitative measurement of receptor activator nuclear K ligand (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline, 1week, 1 and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosed with chronic periodontitis , must be able to maintan good oral hygiene
排除标准
- •Diabetic mellitus immunsuppressive medication
研究组 & 干预措施
Gp I(Melatonin gp)
Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy.
干预措施: Melatonin2%gel (Drug)
Gp II(placebo gp)
Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month
干预措施: PLACEBO (Drug)
结局指标
主要结局
Efficacy of Melatonin gel by determine the change on measurements of clinical parameter in chronic periodontitis.
时间窗: 2 weeks
positive change in clinical parameter by millimeter
EFFICACY of Melatonin Gel by positive change measurements of clinical parameter "pocket depth ,attachment loss"
时间窗: 1: 3 months
positive change in clinical parameter by millimeter
次要结局
- EFFICACY of Melatonin Gel by positive change on concentration level of Receptor activator nuclear K ligand ( RANKL) in Gingival crevicular fluid (GCF)(3 months)
研究者
Shaymaa Hussein Rafat Kotb
principal investigator
Al-Azhar University