Evaluation of the Effects of EndoActivator Use on Postoperative Pain and Root Canal Treatment Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- change from baseline postoperative pain at 1 week
研究概览
简要总结
This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.
详细描述
Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.
Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P < 0.05 considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-60 patient's age
- •Being systemically healthy
- •Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)
排除标准
- •Clinically symptomatic teeth
- •Patients with complicated systemic disease (ASA 3 - 6)
- •Teeth with open apex
- •Teeth having curvature more than 20 degree
- •Not having enough tooth structure to be isolated with rubber dam
- •Patients with severe periodontal defects or deep periodontal pockets (probing depth> 4 mm)
- •A history of taking analgesics 12 hours ago or antibiotics 1 month ago
- •Patients who cannot come to control sessions
结局指标
主要结局
change from baseline postoperative pain at 1 week
时间窗: 1,2,3 and 7 days
Pain was measured using a Verbal Rating Scale with 4 levels, as follows: 0, no pain; 1, slight pain (mild discomfort, no treatment needed); 2, moderate pain (pain required analgesics for relief); 3, severe pain (pain and/or swelling not relieved by simple analgesics and required unscheduled visit) and Wong Baker Face Scale with six different facial expression. Patients were provided forms and asked to record preoperative pain as well as pain at 1,2,3 and 7 days postoperatively, and to note down the number of analgesics taken. Patients returned their completed forms at their 1-week follow-up visits.
change from baseline periapical index at 1 year
时间窗: Clinical and radiographic examinations were performed on the 1 day of treatment, and 1 year after treatment.]
Periapical tissue was evaluated using a 5-point periapical index (PAI) (Ørstavik et al. 1986) and scored as follows: 1: Normal periapical structures; 2: Small changes in bone structures; 3: Changes in bone structure with some mineral loss; 4: Periodontitis with well-defined radiolucent area; 5: Severe periodontitis with exacerbating features. Treatment was considered successful if the patient had no discomfort, no percussion/palpation pain, no sinus tract, no mobility or associated soft-tissue swelling, and a PAI score of ≤ 2. Treatment was considered a failure if the patient could not perform normal masticatory functions, experienced discomfort and percussive pain upon examination, and/or had a PAI score of ≥ 3 .
次要结局
未报告次要终点
研究者
yeldaerdem
Director, Clinical Research
Istanbul Medipol University Hospital