Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.
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
- None
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients
- •Patients with moderate periodontitis
排除标准
- •Pregnant women
- •Lactating women
- •Patients with chronic diseases
研究组 & 干预措施
Phase 1 therapy
干预措施: Scaling and debridement only (Other)
Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel
干预措施: Atorvastatin Calcium (Drug)
Phase 1 therapy with atorvastatin loaded into in-situ gel
干预措施: Atorvastatin Calcium (Drug)
结局指标
主要结局
Probing depth
时间窗: 6 weeks
Plaque index
时间窗: 6 weeks
Bleeding index
时间窗: 6 weeks
次要结局
- Assessment of transforming growth factor in gingival crevicular fluid(6 weeks)
研究者
Heba Amin Elgendy
Teaching assistant - Pharmaceutics Department - Faculty of Pharmacy
Misr University for Science and Technology