The Clinical Comparative Evaluation of Sonic Activation Assisted Irrigation and Apical Enlargement on Postoperative Endodontic Pain In Retreatment: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. The presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.
详细描述
The aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. Patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. One hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. The presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. Postoperative pain will be recorded by each patient by using visual analogue pain scale. Before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. The local anesthetic will be applied before the treatment start. The routine retreatment procedure will be applied. Different final irrigation solutions will be applied in accordance to the manufacturers' instructions. At the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth will be examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.
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
Double (Participant and Outcomes Assessor) The patients and outcome assessor were unaware as to which study group they had been allocated.
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
- 是
入选标准
- •Patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time.
- •Patients who were not included the study who;
- •were pregnant or breast feeding during the duration of the study,
- •have systemic disease, have any pain and/or any facial swelling, abscess,
- •were immunocompromised,
- •were under 18 yrs. and over 65 yrs. age,
- •were taking antibiotics or corticosteroids within previous three days,
- •have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
- •have root canals that could not be well-treated with orthograde retreatment.
排除标准
- •The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
结局指标
主要结局
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week: VAS
时间窗: Baseline, 12, 24, 48, 72 hours and 1 week.
The primary outcome measure of the study is to assess if sonic activation assisted irrigation and apical enlargement procedures influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
次要结局
未报告次要终点