Effect of different irrigant activation systems on GCF levels of NLRP3 and substance P and postoperative pain in patients with symptomatic irreversible pulpitis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in pain levels
研究概览
简要总结
This randomized parallel group, active controlled trial will compare the effects of two irrigant activation systems (ultrasonic activation and laser activation) versus conventional syringe irrigation on inflammatory biomarker levels and postoperative pain in patients with symptomatic irreversible pulpitis undergoing root canal treatment. We hypothesize that activated irrigation will achieve a greater reduction in key inflammatory markers (NLRP3 and substance P) and result in lower postoperative pain scores compared to syringe irrigation. A total sixty patients will be randomized equally into three arms. Primary outcome include pain intensity at 0hr, 6hr ,12hr ,24hr, 48hr, 72hr and 7th day , daily analgesic consumption and patients reported comfort and satisfaction at day 7. And secondary outcome are the changes in biomarker level at 0hr and 7th day. No prior publication exist for this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female individuals aged 16–50 years.
- •Selected teeth.
- •Single rooted mandibular Premolar diagnosed with symptomatic irreversible pulpitis.
- •Teeth with no canal curvature.
排除标准
- •Patients who needed antibiotic prophylaxis in last 3 month
- •Patients with any systemic disease
- •Pregnant females during treatment
- •Patients with intense plaque or calculus on the teeth, redness and bleeding in the gingiva, severe gingivitis, generalized periodontitis, or more than a 3-mm gingival pocket depth will not be included in this study.
结局指标
主要结局
Reduction in pain levels
时间窗: 0hr, 6hr, 12h, 24h, 48h, 72h and 7th day
次要结局
- Reduction in inflammatory biomarkers level(0hr and 7th day)