Effect of Integrated Electronic Apex Locator Modes on Postoperative Pain After Root Canal Retreatment: A 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
- 144
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This randomized controlled clinical trial aimed to evaluate the effect of different integrated electronic apex locator (EAL) modes on postoperative pain following nonsurgical endodontic retreatment. A total of 144 patients requiring retreatment of mandibular premolar teeth with periapical lesions were randomly assigned to four groups.
In the control group, working length was determined using a conventional electronic apex locator. In the experimental groups, an integrated EAL motor was used with three different modes: apical reverse, apical slow down, and apical stop.
All procedures were performed under standardized conditions. Postoperative pain was assessed using a numeric rating scale (NRS) at 6 and 12 hours and on days 1, 2, 3, 5, and 7 after treatment.
The study aimed to determine whether simultaneous working length control using integrated EAL modes influences postoperative pain compared with conventional working length determination.
详细描述
Accurate determination and maintenance of working length is essential for successful endodontic retreatment. Electronic apex locators (EALs) are widely used to improve the accuracy of working length determination. Recently, endodontic motors with integrated EAL systems have been developed, enabling simultaneous working length control during canal instrumentation. These systems incorporate different automatic apical control modes, including apical reverse, apical slow down, and apical stop, which may influence clinical outcomes such as postoperative pain.
This randomized controlled clinical trial was conducted to evaluate the effects of different integrated EAL modes on postoperative pain following nonsurgical endodontic retreatment.
A total of 144 systemically healthy patients with previously treated single-rooted mandibular premolars diagnosed with asymptomatic apical periodontitis were included. Patients were randomly allocated into four groups (n=36 each): (1) conventional electronic apex locator (control group; Root ZX Mini), (2) integrated EAL motor with apical reverse mode, (3) apical slow down mode, and (4) apical stop mode (Ai Motor; Motopex; Woodpecker).
In the control group, working length was determined using a conventional EAL and confirmed radiographically. In the experimental groups, working length determination and instrumentation were performed simultaneously using an integrated EAL motor according to the assigned apical mode.
All retreatment procedures were completed in a single visit under standardized clinical conditions by a single experienced operator. Root canal filling materials were removed, canals were prepared using rotary instruments, and irrigation was performed using 2.5% sodium hypochlorite and 17% EDTA with ultrasonic activation. Final obturation was carried out using a single-cone technique with a bioceramic sealer.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the interventions, the operator could not be blinded. However, participants and the outcome assessor were blinded to group allocation. The statistician was also blinded during data analysis.
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
- •Systemically healthy patients aged between 18 and 65 years
- •Patients requiring nonsurgical endodontic retreatment
- •Single-rooted, single-canal mandibular premolar teeth
- •Diagnosis of asymptomatic apical periodontitis
- •Presence of a well-defined periapical radiolucency (PAI > 4)
- •Teeth with previous root canal treatment performed at least 4 years prior
- •Root canal fillings extending to at least the apical third without overfilling
排除标准
- •Patients with symptoms such as pain, swelling, or sinus tract
- •Patients with a history of smoking or alcohol use
- •Teeth with open apices or root resorption
- •Teeth with intraradicular posts
- •Teeth with insufficient coronal tooth structure
- •Teeth with perforation, instrument fracture, or overfilled canals
- •Teeth with root curvature greater than 30 degrees
- •Teeth with periodontal disease or probing depth >3 mm
- •Cases not suitable for single-visit retreatment
- •Patients who used analgesics within 12 hours prior to treatment
- •Patients who used antibiotics within the last month
- •Patients with cognitive impairment or psychological disorders
研究组 & 干预措施
Conventional Electronic Apex Locator
Working length was determined using a conventional electronic apex locator (Root ZX Mini) and confirmed radiographically. Endodontic retreatment procedures were completed using standardized protocols.
干预措施: Electronic Apex Locator (Device)
Apical Reverse Mode
Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical reverse mode during endodontic retreatment.
干预措施: Integrated Apex Locator Motor (Device)
Apical Slow Down Mode
Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical slow down mode during endodontic retreatment.
干预措施: Integrated Apex Locator Motor (Device)
Apical Stop Mode
Working length determination and canal instrumentation were performed simultaneously using an integrated electronic apex locator motor operating in apical stop mode during endodontic retreatment.
干预措施: Integrated Apex Locator Motor (Device)
结局指标
主要结局
Primary Outcome Measure
时间窗: 6 hours, 12 hours, and days 1, 2, 3, 5, and 7 after treatment
Postoperative pain intensity was assessed using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores were recorded at 6 and 12 hours and on days 1, 2, 3, 5, and 7 following endodontic retreatment.
次要结局
未报告次要终点
研究者
HASAN UYANIK
Researcher, Department of Endodontics
Recep Tayyip Erdogan University