Effect of Sonic Irrigation Activation on Postoperative Pain After Root Canal Treatment in Adults With Asymptomatic Apical Periodontitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 主要终点
- Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled clinical trial will evaluate whether sonic activation of the root canal irrigant using the EndoActivator system reduces postoperative pain after root canal treatment compared with conventional syringe irrigation.
Adults aged 18 to 60 years with pulp necrosis and asymptomatic apical periodontitis involving restorable permanent single-rooted premolars will be eligible to participate. A total of 176 participants will be randomly assigned in a 1:1 ratio to either conventional syringe irrigation or sonic irrigation activation using the EndoActivator system.
Root canal treatment procedures, including instrumentation, irrigant concentration and volume, irrigation delivery, obturation, and postoperative instructions, will be standardized between the two groups. The main difference between the groups will be the method used to activate the irrigant.
The primary outcome will be postoperative pain intensity measured using a 100-mm Visual Analog Scale (VAS) 24 hours after root canal treatment. Pain will also be assessed at 6, 48, and 72 hours and at 7 and 14 days. Additional outcomes will include the proportion of participants reporting pain, rescue analgesic use, time to first analgesic use, total analgesic consumption, and adverse events.
The study will be conducted in the Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Saidu Sharif, Swat, Khyber Pakhtunkhwa, Pakistan. Each participant will be followed for 14 days after treatment.
详细描述
This is a prospective, two-arm, parallel-group randomized controlled clinical trial designed to compare the effect of sonic irrigation activation with conventional syringe irrigation on postoperative pain following root canal treatment in adults with pulp necrosis and asymptomatic apical periodontitis.
Eligible participants will be adults aged 18-60 years requiring primary root canal treatment of restorable permanent single-rooted premolars. Participants must have a clinical diagnosis of pulp necrosis and radiographic evidence of apical periodontitis/periapical radiolucency without spontaneous preoperative pain or clinically significant pain on percussion or palpation. Participants with symptomatic apical periodontitis, acute apical abscess, previous endodontic treatment, root fracture, severe root curvature, open apices, root resorption, severely calcified or obliterated canals, severe periodontal disease, or other specified exclusion criteria will not be enrolled.
A total of 176 participants will be recruited and allocated in a 1:1 ratio using a computer-generated randomization sequence with variable block randomization. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. The operator cannot be blinded because the irrigation activation method must be known during treatment. However, the postoperative outcome assessor will remain blinded to treatment allocation, and the statistician will analyze coded treatment groups.
In the conventional irrigation group, final irrigation will be performed using a sterile side-vented endodontic irrigation needle positioned approximately 1-2 mm short of the working length. In the sonic activation group, the same irrigants, concentrations, volumes, sequence, and exposure times will be used, followed by activation using the EndoActivator system. The EndoActivator tip will be positioned approximately 1-2 mm short of the established working length without binding. The activation protocol will be standardized before recruitment.
The primary outcome will be postoperative pain intensity measured on a 100-mm Visual Analog Scale, with 0 mm representing no pain and 100 mm representing the worst imaginable pain, assessed at 24 hours after treatment. Secondary outcomes will include pain intensity at 6, 48, and 72 hours and 7 and 14 days; the proportion of participants reporting postoperative pain; requirement for rescue analgesics; time to first analgesic use; total number of analgesic tablets consumed during the 14-day follow-up; and adverse events or procedural complications.
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 operator cannot be blinded because the assigned irrigation technique must be known during treatment. The postoperative outcome assessor will remain blinded to treatment allocation. The statistician will analyze coded treatment groups without knowledge of treatment identity.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years.
- •Either sex.
- •Restorable permanent single-rooted premolar requiring primary root canal treatment.
- •Clinical diagnosis of pulp necrosis.
- •Radiographic evidence of apical periodontitis or periapical radiolucency.
- •Absence of spontaneous preoperative pain.
- •No clinically significant pain on percussion or palpation.
- •No swelling, sinus tract, or purulent drainage.
- •Adequate periodontal support.
- •No previous endodontic treatment.
- •Ability to understand and use the pain-rating scale.
- •Willingness to comply with postoperative follow-up.
- •Provision of written informed consent.
排除标准
- •Symptomatic apical periodontitis or acute apical abscess.
- •Preoperative spontaneous pain.
- •Swelling or sinus tract.
- •Previously treated teeth.
- •Root fracture.
- •Severe root curvature.
- •Open apices.
- •Root resorption.
- •Severely calcified or obliterated canals.
- •Severe periodontal disease.
- •Systemic disease likely to substantially influence pain perception or healing.
- •Use of analgesic or anti-inflammatory medication within 48 hours before treatment.
- •Recent antibiotic therapy.
- •Inability to complete postoperative follow-up.
研究组 & 干预措施
Conventional Syringe Irrigation
Participants will receive standardized root canal treatment with conventional syringe irrigation using a sterile side-vented endodontic irrigation needle. The needle will be positioned approximately 1-2 mm short of the established working length without binding. Irrigation will be performed using gentle, standardized short vertical movements. The same irrigants, concentrations, volumes, sequence, exposure times, and other treatment procedures will be used as in the sonic activation group. No mechanical activation device will be used.
干预措施: Conventional Syringe Irrigation (Procedure)
Sonic Irrigation Activation Using EndoActivator
Participants will receive standardized root canal treatment with sonic irrigation activation using the EndoActivator system. The same irrigants, concentrations, volumes, sequence, and exposure times used in the conventional irrigation group will be applied. A flexible polymer EndoActivator tip of appropriate size will be positioned approximately 1-2 mm short of the established working length without binding. Sonic activation will be performed using a prespecified activation protocol, with the tip moved in a controlled manner within the irrigant-filled canal. Tip size, device setting, activation duration, number of cycles, and insertion depth will be recorded.
干预措施: Sonic Irrigation Activation Using EndoActivator (Procedure)
结局指标
主要结局
Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS)
时间窗: 24 hours after root canal treatment
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 mm representing no pain and 100 mm representing the worst imaginable pain. Higher VAS scores indicate greater postoperative pain.
次要结局
- Postoperative Pain Intensity Measured Using a 100-mm Visual Analog Scale (VAS) at Follow-Up(6 hours, 48 hours, 72 hours, 7 days, and 14 days after root canal treatment)