Effect of Number of Rotary Instruments on Negotiating Second Mesiobuccal Canals to Working Length and on Postoperative Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- Postoperative Pain Intensity (VAS Score)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effect of the number of rotary files on working length negotiation and postoperative pain in the second mesiobuccal (MB2) canals of maxillary first molars. Patients are assigned to one of four groups according to the number of rotary files used: single-, two-, three-, or four-file systems. Postoperative pain is assessed on each of the seven consecutive postoperative days (Days 1-7) using a visual analog scale (VAS), and working length negotiation success is recorded during canal instrumentation.
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 (Outcomes Assessor)
盲法说明
The outcome assessor evaluating VAS scores and clinical data was blinded to the instrumentation groups.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy individuals aged between 20 and 65 years
- •Requiring primary endodontic treatment of maxillary first molars
- •Diagnosis of asymptomatic apical periodontitis based on clinical and radiographic findings
- •Presence of a second mesiobuccal (MB2) canal in the maxillary first molar
- •Absence of preoperative pain or symptoms
- •Teeth with periapical lesions smaller than 5 mm in diameter
- •Ability to comply with follow-up visits and effectively communicate during the treatment process
排除标准
- •Presence of symptomatic apical periodontitis or acute apical abscess
- •Need for retreatment of previously treated teeth
- •Use of medications such as narcotics, antibiotics, sedatives, or antidepressants within one week prior to treatment
- •Presence of a sinus tract, periapical abscess, or facial cellulitis
- •Pregnancy
- •Inability to understand or follow the study instructions
研究组 & 干预措施
Three-file rotary instrumentation (VDW Rotate)
Root canal instrumentation was performed using a three-file rotary system (VDW Rotate; VDW GmbH, Munich, Germany). Instrumentation was performed sequentially using 15/.04, 20/.05, and 25/.04 files with brushing-pecking motions in 2-3 mm increments. All files were operated at 300 rpm, with torque settings of 1.3 Ncm for the 15/.04 file, 2.1 Ncm for the 20/.05 file, and 2.3 Ncm for the 25/.04 file.
干预措施: VDW Rotate (Device)
Two-file rotary instrumentation (Perfect Super System Minimal Invasive)
Root canal instrumentation was performed using a two-file rotary system (Perfect Super System Minimal Invasive; Perfect Medical Instruments Co. Ltd, Shenzhen, China). A 10/.06 Shaper file was used as an initial file to reach working length with a brushing motion, followed by a 25/.04 Finisher file. Both files were operated at 300 rpm and 2.0 Ncm torque.
干预措施: Perfect Super System Minimal Invasive Kit (Device)
Single-file rotary instrumentation (One Curve)
Root canal instrumentation was performed using a single-file rotary system (One Curve; Micro-Mega, Besançon, France). A 25/.04 One Curve file was used at 300 rpm and 2.5 Ncm torque with gentle pecking motions. The file was cleaned and withdrawn every 2-3 mm during advancement to the full working length.
干预措施: One Curve Rotary File (Device)
Four-file rotary instrumentation (Perfect Super System Advanced Kit)
Root canal instrumentation was performed using a four-file rotary system (Perfect Super System Advanced Kit; Perfect Medical Instruments Co. Ltd, Shenzhen, China). A crown-down preparation was performed up to the apical third using a 10/.07 Opener file at 300 rpm and 2.5 Ncm torque. A 10/.04 glider file was then used at 250 rpm and 1.0 Ncm torque to reach the root apex and prepare the apical third. Instrumentation was completed using 17/.05 and 25/.04 files, both operated at 300 rpm and 2.5 Ncm torque.
干预措施: Perfect Super System Advanced Kit (Device)
结局指标
主要结局
Postoperative Pain Intensity (VAS Score)
时间窗: Daily assessment for 7 consecutive days following treatment (Days 1-7)
Postoperative pain will be assessed using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst possible pain imaginable."
次要结局
未报告次要终点
研究者
Mehmet Adıgüzel
Associate Professor
Mustafa Kemal University