Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasonic Irrigation Activation, Laser-Activated Irrigation, Mechanical Irrigation Activation, Negative Pressure Irrigation.
- Who it may be relevant to
- Registry conditions: Dental Pulp Necrosis, Pulpitis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Metagenomic Analysis and Post-operative Pain Assessment of Infected Root Canals Using Different Irrigation Protocols: A Randomized Controlled Clinical Trial
Overview
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.
Detailed description
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)
Group 4: Negative Pressure Irrigation (PulpSucker device)
Procedures: All patients will undergo standardized root canal preparation using rotary nickel-titanium files. Pre-irrigation bacterial samples will be collected before instrumentation, and post-irrigation samples will be collected after the irrigation protocol. All samples will undergo next-generation sequencing (NGS) for metagenomic analysis to assess bacterial reduction and community composition changes.
Outcomes: Postoperative pain will be evaluated using the Visual Analogue Scale (VAS) at 6 hours, 24 hours, 48 hours, and 7 days post-treatment. Statistical analyses will compare bacterial reduction efficacy and pain levels across all four groups.
Interventions
- Procedure Ultrasonic Irrigation Activation
Sodium hypochlorite irrigation activated with ultrasonic device - Procedure Laser-Activated Irrigation
Laser-activated sodium hypochlorite with methylene blue photosensitizer - Procedure Mechanical Irrigation Activation
Mechanical activation device creating swirling motion - Procedure Negative Pressure Irrigation
Continuous irrigation with negative pressure suction
Primary outcome measures
- Outcome 1: Bacterial Reduction [Time frame: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)]
- Outcome 2: Postoperative Pain Level [Time frame: 6 hours, 24 hours, 48 hours, and 7 days post-treatment]
Secondary outcome measures (2)
- Bacterial Community Composition [Time frame: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)]
- Correlation Between Bacterial Reduction and Pain [Time frame: Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Endodontic Clinic, Faculty of Dentistry, Suez Canal University — Ismailia
Identifiers
NCT: NCT07546773 · REC 928/2024 · REC 928/2024