Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasonic Irrigation Activation: Sodium hypochlorite irrigation activated with ultrasonic device

Laser-Activated Irrigation: Laser-activated sodium hypochlorite with methylene blue photosensitizer

Mechanical Irrigation Activation: Mechanical activation device creating swirling motion

Negative Pressure Irrigation: Continuous irrigation with negative pressure suction

Study summary

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.

Eligibility

Primary outcome measure(s)

• Outcome 1: Bacterial Reduction — 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 — 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)

Trial sites (1)

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