Comparison of Postoperative Pain When Using an Endodontic Needle and Endo1 Ultrasonic Endo Activate Device During Root Canal Irrigation: A Randomized Controlled Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Summary:
After a root canal procedure, it is common to experience postoperative pain. Cleaning the root canal thoroughly is crucial for pain relief, but removing all debris with standard methods is difficult. Irrigation, using either traditional endodontic needles or newer methods like endodontic activation, helps clean the canal. This study aims to compare pain levels after using conventional needles versus an Endo1 Ultrasonic Endo Activate Device for irrigation. Patients will undergo standard root canal preparation and then be randomly assigned to one of two groups for final irrigation: the Endo1 device (EA) and the conventional endodontic needles (EN). The study will provide insights into which method is more effective in reducing postoperative pain.
详细描述
Background:
One of the primary objectives following root canal therapy is to alleviate pain. While postoperative pain is undesirable, it is often considered a common sensation following endodontic treatment.
Completely removing all organic and inorganic debris from the root canal system to ensure the elimination of irritants that can cause postoperative pain is a challenging task, even when using precise rotary, hand, or hybrid instruments. Therefore, irrigation plays a crucial role in the cleaning and shaping process.
Traditional root canal irrigation typically involves the use of an endodontic needle (EN) to disinfect the root canal. However, a newer approach called endodontic activation (EA) has been suggested to enhance root canal disinfection by activating irrigants within the canal.
Both of these methods of root canal irrigation are routine practice and part of the standard root canal treatment.
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 (Participant)
盲法说明
Patients will be masked from the procedure
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years of age) visiting the College of Dentistry and undergoing root canal treatment in posterior teeth (molars and premolars).
- •Teeth having fully formed roots with mature apices.
- •Patients willing to collaborate in the study must sign a written consent form.
- •Diagnosis of irreversible pulpitis in posterior tooth/teeth requiring root canal treatment.
- •No history of allergy to the anesthesia solution.
- •Classified as class I, II in the American Society of Anesthesiologists Physical Status Classification System.
排除标准
- •Patients diagnosed with pulp necrosis in the tooth require root canal treatment.
- •Mentally or medically compromised patients.
- •Pregnant women.
- •Patients on any medications for the past two weeks
- •Patients who refuse to participate in the study.
- •Patients with a history of allergy from any of the contents of local anesthesia or rubber dam material.
- •Non-restorable teeth
研究组 & 干预措施
Endodontic needle (EN)
In this group, the irrigation of root canals will be done with 5.25 % sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The tip of the needle will be pre-measured and positioned within 1 millimeter of the working length. No activation of the irrigant will be performed.
干预措施: endodontic needle (EN) (Procedure)
Endodontic activation (EA)
In this group, the irrigation of root canals will be done with 5.25% sodium hypochlorite. The delivery of the irrigant will be done using a 30-gauge side-vented closed-end irrigation needle (NaviTip, Ultradent). The irrigant will be activated with ultrasonic energy using the Endo-1 Ultrasonic Endo Activate (Guilin Woodpecker, Guilin, China). The tip of the Endo-1 Ultrasonic Endo Activate device will be pre-measured and kept within 1 mm from the working length. The manufacturer's instructions regarding irrigant activation will be followed.
干预措施: Endodontic activation (EA) (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: 1 week postoperatively
Postoperative pain will be measured using the Heft-Parker visual analog scale (VAS)
次要结局
- Irrigation time(During root canal treatment)
研究者
Muhammad Zubair Ahmad
Associate Professor
Qassim University