Evaluation of the Effect of Sonic Activation Using the EDDY Device on Root Canal Microbiota and Postoperative Pain in Teeth With Asymptomatic Apical Periodontitis: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Bacterial Load (CFU/mL) After Root Canal Treatment
研究概览
简要总结
This randomized controlled clinical trial aimed to evaluate the effect of sonic activation using the EDDY device on root canal microbiota and postoperative pain in teeth with asymptomatic apical periodontitis. Forty patients were assigned to either a sonic activation group (EDDY) or a conventional irrigation group. Bacterial samples were collected before and after root canal treatment and analyzed using real-time PCR. Postoperative pain was assessed using a Numerical Rating Scale at various time intervals. The results showed that EDDY sonic activation significantly reduced bacterial load, while no statistically significant difference was found in postoperative pain between the groups.
详细描述
This prospective, randomized controlled clinical trial was conducted to assess the impact of sonic irrigation using the EDDY device on the reduction of intracanal microbiota and on postoperative pain following root canal treatment of teeth with asymptomatic apical periodontitis. Forty participants with single-rooted teeth were randomly allocated into two groups: the EDDY group, which received final irrigation activated with the EDDY sonic system, and the control group, which received conventional syringe irrigation. Microbiological samples were collected before and after instrumentation and were analyzed using real-time PCR to detect specific bacterial taxa. Postoperative pain levels were recorded using the Numerical Rating Scale at multiple time intervals up to 48 hours after treatment. The results demonstrated a statistically significant reduction in bacterial load in the EDDY group compared to the control group, but no significant difference in postoperative pain was observed. The findings support the use of EDDY sonic activation as an effective method for enhancing root canal disinfection.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Presence of a single-rooted tooth diagnosed with asymptomatic apical periodontitis
- •No previous endodontic treatment on the involved tooth
- •Good general health (ASA I or II)
- •Ability to provide informed consent
排除标准
- •Teeth with internal or external resorption
- •Pregnant or breastfeeding women
- •Systemic antibiotic or anti-inflammatory drug use within the past 30 days
- •Patients with periodontal pockets >4 mm on the affected tooth
- •Known allergy to sodium hypochlorite or EDTA
- •Patients who failed to attend postoperative pain follow-up
研究组 & 干预措施
EDDY Group
Patients in this group received final irrigation using the EDDY sonic activation device after standard root canal instrumentation.
干预措施: EDDY Sonic Activation (Device)
Conventional Irrigation Group
Patients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation.
干预措施: Conventional Syringe Irrigation (Procedure)
结局指标
主要结局
Change in Bacterial Load (CFU/mL) After Root Canal Treatment
时间窗: Baseline and immediately after instrumentation (same visit)
Bacterial samples were taken from the root canal before and after treatment. Quantitative changes in bacterial load were assessed using real-time PCR analysis of selected bacterial taxa.
次要结局
- Postoperative Pain Level(6, 12, 24, and 48 hours after treatment)
研究者
Abdulkadir Tiftik,DDS
Specialist in Endodontics / Researcher
Bezmialem Vakif University