Effect of Different Apical Actions on Local Inflammatory Mediators and Pain During Root Canal Preparation: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Substance P
研究概览
简要总结
The goal of this clinical trial is to determine patients' the inflammation and pain response to different apical actions used in rotary instrumentation during root canal shaping process. The main questions it aims to answer are:
- How the different apical actions of endodontic motors influence the pain and inflammatory mediator release from the periapical region of related tooth?
- Does the perceived pain differ among the used apical action methods after the root canal preparation?
- Are the perceived pain and local pain mediator levels coherent?
Participants will:
Attend to the root canal treatment in the endodontics clinic. The treatment will be two visits.
Answer the Visual Analog Scale questionnaire on day 0 (first appt.) and Day 3 (second appt.) Keep a diary of their symptoms and the number of times they use an anti-inflammatory drug.
详细描述
Study Protocol
This study will include patients aged 18-49 years who present to the İzmir Katip Çelebi University, Department of Endodontics, requiring root canal treatment for vital, lesion-free mandibular first and second molars. Patients with systemic diseases will be excluded. The study will involve 66 patients. The sample size was calculated according to the effect size of 0,25 recommended by Cohen (1988).
Pre-Treatment Assessment:
- Patients will be asked about spontaneous pain and percussion pain related to the affected tooth prior to the session.
- These pain levels will be recorded using the Visual Analog Scale (VAS).
Group Allocation:
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)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild, moderate pulpitis and pulpal expose patients in need of root canal -treatment to their mandibular premolars.
- •Healthy periodontal tissue with Periapical Index under
- •Helathy adjacent teeth.
排除标准
- •Systemic diseases
- •Percussion pain
- •Patients who did not consent to a vital pulp therapy
- •Radiologically seen open apex, root resorption, calcification
- •Periodontal pocket beyond 4mm in length
- •Consumption of Antibiotics or Corticosteroids 1 month before the treatment
- •Consumption of antiinflammatory drugs 2 days before the treatment
结局指标
主要结局
Substance P
时间窗: From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.
The local Substance P amount will be assesed with ELISA kits
次要结局
- Visual Analog Scale(From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.)
- Inflammatory Mediator: IL-1ß(From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.)
- Inflammatory Mediator: IL-6(From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.)
- Inflammatory Mediator: TNF alpha(From Day 0 to Day 3. The last measurement will be taken just before the end of the interventional treatment.)
研究者
Emrah Karataşlıoğlu
Associate Prof. Dr.
Izmir Katip Celebi University