The Effect of Different Sodium Hypochlorite Concentrations and Activation Techniques on Postoperative Pain in Permanent Molars With Chronic Apical Periodontitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial was to evaluate the effect of different sodium hypochlorite (NaOCl) concentrations and irrigation activation techniques on the intensity of postoperative pain following single-visit root canal treatment in molar teeth with asymptomatic chronic apical periodontitis.
The primary research questions of this study were as follows:
Does using 2.5% or 5.25% sodium hypochlorite solution during root canal irrigation influence the severity of postoperative pain? Do activation techniques such as sonic activation using EDDY (a flexible polyamide tip-driven sonic irrigation device operating at 6,000 Hz; VDW GmbH, Munich, Germany) or passive ultrasonic irrigation (PUI) significantly reduce postoperative pain compared to conventional needle irrigation? In the non-activation groups, root canals were irrigated with 2.5% or 5.25% NaOCl using a 30-gauge side-vented needle without any further activation.
In the EDDY groups, root canals were irrigated using 2.5% or 5.25% NaOCl, followed by activation with a flexible polyamide EDDY tip (25/04) at 6,000 Hz, three times for 20 seconds.
In the PUI groups, root canals were irrigated using 2.5% or 5.25% NaOCl, and then subjected to passive ultrasonic activation with a suitable ultrasonic tip three times for 20 seconds, without contacting dentinal walls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 16 and 60 years
- •Systemically healthy individuals
- •Presence of mandibular or maxillary first or second molar diagnosed with asymptomatic chronic apical periodontitis
- •Negative response to electric pulp test, cold test, percussion and palpation tests
- •Teeth eligible for single-visit root canal treatment
- •Patients who provided written informed consent
排除标准
- •Pregnant or breastfeeding individuals
- •Patients with uncontrolled systemic diseases (e.g., uncontrolled hypertension, uncontrolled diabetes mellitus, chronic renal failure, hematologic disorders)
- •Patients undergoing chemotherapy or radiotherapy
- •Individuals with infective endocarditis or immunosuppressive conditions
- •Patients requiring antibiotic prophylaxis prior to dental treatment
- •Use of anti-inflammatory or analgesic medications within 24 hours before treatment
- •Teeth with calcified canals, internal/external resorption, or root fractures
- •Patients unable to attend follow-up appointments or complete pain assessment forms
研究组 & 干预措施
2.5% NaOCl - Neddle Irrigation
Irrigation was performed with a 30 G side-vented needle using 2.5% sodium hypochlorite (NaOCl). A total of 11 mL NaOCl was used: 2 mL after coronal preparation, 2 mL after middle third, 2 mL after apical third preparation, and 5 mL as final irrigation. Canals were then flushed with 2 mL saline and 2 mL 17% Ethylenediaminetetraacetic Acid (EDTA).
2.5% NaOCl - EDDY Activation
Following 2 mL irrigation with 2.5% NaOCl, canals were activated using the EDDY sonic system (25/04 polyamide tip, 6000 Hz) 2 mm short of working length for 20 seconds, repeated 3 times. Between activations, 1 mL NaOCl was used. Total 11 mL NaOCl was delivered. Final irrigation was performed with 2 mL saline and 2 mL 17% EDTA.
干预措施: EDDY Sonic Activation System (Device)
2.5% NaOCl - Passive Ultrasonic Irrigation
Canals were irrigated with 2 mL 2.5% NaOCl and activated using a passive ultrasonic tip without contact with dentin walls, 2 mm short of working length for 20 seconds, repeated 3 times. Each cycle was followed by 1 mL NaOCl. Final irrigation included 2 mL saline and 2 mL 17% EDTA.
干预措施: Passive Ultrasonic Irrigation (PUI) (Device)
5.25% NaOCl - Needle Irrigation
Irrigation was performed with a 30 G side-vented needle using 5.25% sodium hypochlorite. A total of 11 mL NaOCl was used as in the other groups. Final irrigation included 2 mL saline and 2 mL 17% EDTA.
5.25% NaOCl - EDDY Activation
Following 2 mL irrigation with 5.25% NaOCl, EDDY activation was performed (as described in Arm 2), with 1 mL NaOCl used between activations. Final irrigation was performed with 2 mL saline and 2 mL 17% EDTA.
干预措施: EDDY Sonic Activation System (Device)
5.25% NaOCl - Passive Ultrasonic Irrigation
After irrigation with 2 mL of 5.25% NaOCl, canals were activated using a passive ultrasonic tip (as in Arm 3), with 1 mL NaOCl used between activations. Final irrigation consisted of 2 mL saline and 2 mL 17% EDTA.
干预措施: Passive Ultrasonic Irrigation (PUI) (Device)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: up to 72 hours
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
次要结局
未报告次要终点
研究者
Kübra Gürler
Principal Investigator
Cukurova University