Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.
详细描述
In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.
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
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.
排除标准
- •Any systemic disease that affects the periodontium. ·
- •Pregnant, postmenopausal women. ·
- •People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
- •People who use mouth washes regularly ·
- •Participation in other clinical trials.
研究组 & 干预措施
oral hygiene instructions and SRP of all teeth plus placebo gel.
干预措施: SRP of all teeth (Procedure)
oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.
干预措施: spirulina gel (Drug)
oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.
干预措施: SRP of all teeth (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: 3 months
Clinical attachment level was measured at baseline, 1 and 3 months after gel application.
Probing pocket depth
时间窗: 3 months
Probing pocket depth was measured at baseline, 1 and 3 months after gel application.
Interleukin 6.
时间窗: 3 months
Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.
次要结局
- Plaque Index(3 months)
- Gingival index(3 months)
研究者
Enas Elgendy
Prof. of Oral Medicine and Periodontology
Kafrelsheikh University