Metagenomic Analysis and Post-operative Pain Assessment of Infected Root Canals Using Different Irrigation Protocols: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome 1: Bacterial Reduction
研究概览
简要总结
Achieving effective root canal disinfection while minimizing postoperative pain is a critical goal in endodontic therapy. Advanced irrigation protocols, such as ultrasonic activation, laser activation, negative pressure irrigation (PulpSucker device), and mechanical activation (Easy Clean device), have shown promise in enhancing bacterial reduction within the root canal system. However, their impact on postoperative pain has not been fully explored.
This randomized controlled clinical trial aims to compare bacterial reduction and postoperative pain levels in infected root canals using four different irrigation protocols. The study will use metagenomic analysis to evaluate changes in bacterial community composition and the Visual Analogue Scale (VAS) to assess patient-reported pain levels at multiple time points postoperatively.
详细描述
Background: Effective bacterial reduction in root canals remains a significant challenge in endodontics due to complex bacterial communities, including species like Enterococcus faecalis that resist conventional treatment methods. Advanced irrigation protocols offer innovative solutions by disrupting biofilms and ensuring deeper penetration of irrigants into apical regions of the canal system.
Study Design: This is a randomized, parallel-group clinical trial involving 40 adult patients (18-60 years) requiring root canal treatment for teeth with necrotic pulp and periapical radiolucency. Patients will be randomly assigned to one of four irrigation protocol groups (10 patients per group):
Group 1: Ultrasonic Activation
Group 2: Laser Activation with methylene blue
Group 3: Mechanical Activation (Easy Clean device)
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
- None
盲法说明
The operator performing treatment must know which irrigation protocol is used (ultrasonic, laser, Easy Clean, PulpSucker), so participants and care providers are not masked.
One of your main outcomes is patient-reported pain (VAS), so the participant is the outcome assessor for that endpoint and cannot realistically be blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-60 years
- •Requiring root canal treatment for teeth with necrotic pulp
- •Presence of periapical radiolucency confirmed radiographically
- •Good general health with no systemic diseases affecting healing outcomes
- •Willing to provide informed written consent
- •Available for follow-up appointments
排除标准
- •Patients with open apices
- •Severe periodontal disease
- •Currently taking antibiotics
- •Allergy to study materials (lidocaine, sodium hypochlorite, methylene blue, latex)
- •Pregnant or breastfeeding women
- •Compromised immunity or systemic conditions (e.g., uncontrolled diabetes, HIV, immunosuppressive therapy)
- •Previous root canal treatment on the study tooth
- •Tooth not restorable
- •Presence of vertical root fracture
研究组 & 干预措施
Ultrasonic Activation
Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip).
干预措施: Ultrasonic Irrigation Activation (Procedure)
ARM 2: Laser Activation
Root canals will be irrigated with NaOCl activated using a diode laser device (Elexxon Pico, Germany) with methylene blue (0.1 mg/mL) as a photosensitizer to enhance antimicrobial effects.
干预措施: Laser-Activated Irrigation (Procedure)
ARM 3: Mechanical Activation (Easy Clean)
Root canals will be irrigated with NaOCl, activated mechanically using the Easy Clean device (BassiEndo) to create a swirling motion for improved disinfection.
干预措施: Mechanical Irrigation Activation (Procedure)
ARM 4: Negative Pressure Irrigation (PulpSucker)
Root canals will be irrigated with NaOCl using the PulpSucker device (PlanB dental), which employs negative pressure irrigation to ensure continuous delivery and debris removal.
干预措施: Negative Pressure Irrigation (Procedure)
结局指标
主要结局
Outcome 1: Bacterial Reduction
时间窗: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
Change in bacterial load (CFU/mL or relative abundance via metagenomic sequencing). Bacterial samples collected before and after irrigation protocol using sterile paper points, analyzed via next-generation sequencing (NGS) to assess bacterial reduction and changes in microbial community composition
Outcome 2: Postoperative Pain Level
时间窗: 6 hours, 24 hours, 48 hours, and 7 days post-treatment
Patient-reported pain intensity using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-9=severe tolerable pain, 10=severe intolerable pain. Measure: Visual Analogue Scale (VAS) score (0-10 scale)
次要结局
- Bacterial Community Composition(Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation))
- Correlation Between Bacterial Reduction and Pain(Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days)
研究者
Salma gohar
Assistant Lecturer, Department of Endodontics
Suez Canal University