Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Bacterial Levels
研究概览
简要总结
The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals.
详细描述
Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teeth with necrotic pulps and asymptomatic apical periodontitis
排除标准
- •patients who had received antibiotics during the previous 3 months or had any general disease,
- •teeth that could not be properly isolated with rubber dam,
- •non-restored teeth,
- •periodontal pockets depths greater than 4 mm,
- •previous endodontic treatment,
- •open apex,
- •crown/root fracture
- •root resorption or calcifications.
研究组 & 干预措施
Passive Ultrasonic Irrigation Protocol
ultrasonic activation of antimicrobial solutions
干预措施: Ultrasonic Irrigation (Device)
Non-Ultrasonic Irrigation Protocol
no-activation of antimicrobial solutions
干预措施: Non-Ultrasonic Irrigation (Device)
结局指标
主要结局
Bacterial Levels
时间窗: Through study completion, an average of 2 years
Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
次要结局
- Endotoxin Levels(Through study completion, an average of 2 years)
研究者
Ericka Tavares Pinheiro
PhD
University of Sao Paulo