Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- controlled release of the drug with associated with infection inhibition
研究概览
简要总结
Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections
详细描述
Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin, resulting in treatment-resistant periradicular lesions. To overcome these problems, antibacterial nanoparticles were used because of their small size, sustained release and positive charge which interact with the negatively charged surface of bacterial cell causing its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity, gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining bacterial reduction percent and biofilm inhibition assay
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
- •History of recurrent acute and/or chronic periapical abscess
- •Pain on palpation and/or percussion at least after one month of previous procedure
- •Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.
排除标准
- •Teeth that were badly broken down indicated for extraction or with difficult isolation
- •Immuno-compromised patients.
- •Patients with history of taking antibiotics orally.
- •Periodontally affected teeth.
研究组 & 干预措施
Free drug
Free drug incorporated in in situ gels
干预措施: Ciprofloxacin (Drug)
drug entrapped in nanoparticles
drug entrapped in nanoparticles then incorporated in in situ gels
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
controlled release of the drug with associated with infection inhibition
时间窗: two weeks
drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection
次要结局
未报告次要终点
研究者
Mona Gamal Mohamed Afifi Arafa
Associate Professor
British University In Egypt