Clinical Study: Evaluation of the Antibacterial Effect of Insoluble Antibacterial Nanonparticles Incorporated in Dental Materials for Endodontic Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- In vitro evaluation
研究概览
简要总结
The effect of Antibacterial Nanoparticles, Incorporated in root canal sealer material and in provisional restoration is going to be examined. Two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) An evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.We assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.
详细描述
- patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
- patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. Two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. The control group (40 patients) will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.While preparing the post, a small example of the sealer will be taken to a test in the lab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Needs root canal treatment
- •For the provisional restoration- molar teeth with class II restoration
- •For the provisional restoration-healty/ uninfected teeth
- •For the root canal sealer- single root canal
- •For root canal sealer-infected teeth
排除标准
- •systemic health problems
- •Pregnant women
- •The use of antiseptic mouth rinse or antibiotic Up to 2 weeks before the beginning of study
结局指标
主要结局
In vitro evaluation
时间窗: One month for provisional restoration.
clinical and radiological evaluation of the radiolucent periapical lesion, for the root canal sealer. As for the provisional restoration, in vitro assesment of bacterial growth.
次要结局
- Radiological evaluation of the root canal sealer(1 year for the root canal sealer.)
- Clinical and in vitro evaluation of the root canal sealer(1 year for the root canal sealer.)
研究者
Perez Davidi Michael
DMD
Hadassah Medical Organization