Can Instrumentation Kinematics Affect Post Operative Pain and Substance P Levels? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- difference in substance P levels
研究概览
简要总结
The aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance P levels in patients with irreversible pulpitis with symptomatic apical periodontitis. Twenty patients were randomly distributed into two groups; Continuous Rotation group(n=10): received mechanical preparation using EdgeEndo x7 rotary system (Albuquerque, New Mexico, USA), while Reciprocation group(n=10): received mechanical preparation using EdgeOne Fire reciprocating system (Albuquerque, New Mexico, USA). Apical fluid(AF) samples were collected, and substance P (SP) levels were measured using radioimmunoassay and postoperative pain was measured using Numerical Rating Scale (NRS) preoperatively, at 6h, 12h, 24h, 48h and 72h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single rooted mandibular second premolar teeth with complete root formation
- •Pulpal diagnosis: Symptomatic irreversible pulpitis
- •Periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area
- •Patients with pre-operative pain records above 4 on Numerical Rating Scale (NRS) to ensure standardization
排除标准
- •The presence of any systemic disease or allergic reactions
- •Pregnant and lactating females
- •Patients on antibiotic or anti-inflammatory medication
- •Use of analgesics a week prior to treatment
- •A radiographically untraceable canal or an excessively curved root
- •The presence of periapical radiolucency or sinus tract.
- •Teeth with open apices
- •Severe periodontal disease (generalized or localized to the tooth in question)
- •Absence of bleeding in the pulp chamber on access cavity preparation
- •Internal or external resorption
结局指标
主要结局
difference in substance P levels
时间窗: pre-operatively and after 5 days at the beginning of the second visit
tested by radioimmunacy (ELISA)
post operative pain levels
时间窗: pre-operative, after 6 hours, 12 hours , 24 hours, 48 hours, 72 hours
Numerical Rating Scale was used to assess pain where 0 is no pain and 10 is the worst possible pain
次要结局
未报告次要终点
研究者
Salma Talaat
principal investigator
Ain Shams University