Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial
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
- Clinical attachment loss
研究概览
简要总结
the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.
详细描述
Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm
- •patients with normal lipid profile
- •nonsmokers
- •patients free from any systemic disorders
- •committed patients to complete the treatment with follow-ups.
排除标准
- •patients with hyperlipidemia
- •patients taking lipid lowering drugs
- •Lactating women women, patients with mental or psychological illness and medically compromised patients.
研究组 & 干预措施
Plain chitosan gel group
After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .
干预措施: open flap subgingival debridement (Procedure)
Plain chitosan gel group
After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .
干预措施: Subgingival injection of chitosan 2% gel (Procedure)
Chitosan gels containing free Simvastatin
Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
干预措施: open flap subgingival debridement (Procedure)
Chitosan gels containing free Simvastatin
Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
干预措施: Subgingival injection of chitosan 2% gel (Procedure)
Chitosan gels containing Simvastatin microsponges
This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .
干预措施: open flap subgingival debridement (Procedure)
Chitosan gels containing Simvastatin microsponges
This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .
干预措施: Subgingival injection of chitosan 2% gel (Procedure)
结局指标
主要结局
Clinical attachment loss
时间窗: By the end of study after 6 months of 6 months
Will be measured in millimetre
Pocket depth
时间窗: By the end of study after 6 months of 6 months
Will be measured in millimetre
Pocket depth
时间窗: Before the beginning of study
Will be measured in millimetre
Clinical attachment loss
时间窗: Before beginning of the study
Will be measured in millimetre
次要结局
未报告次要终点
研究者
Ahmed Mortada
Lecturer at the Department of Periodontology and Oral Implantology , Faculty of Dentistry , Assiut University, Egypt
Assiut University