Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Pr… (NCT07546773) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols
Egypt40 participantsStarted 2026-04-30
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Outcome 1: Bacterial Reduction
Timeframe: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
2
Outcome 2: Postoperative Pain Level
Timeframe: 6 hours, 24 hours, 48 hours, and 7 days post-treatment