An interventional study of Ultrasonic Irrigation Activation and Laser-Activated Irrigation in Dental Pulp Necrosis and Pulpitis, sponsored by Suez Canal University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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.
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.
156 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 40 is below the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip).
Procedure: Ultrasonic Irrigation 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.
Procedure: Laser-Activated Irrigation
Root canals will be irrigated with NaOCl, activated mechanically using the Easy Clean device (BassiEndo) to create a swirling motion for improved disinfection.
Procedure: Mechanical Irrigation Activation
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.
Procedure: Negative Pressure Irrigation
Sodium hypochlorite irrigation activated with ultrasonic device
Also known as: Group-I
Laser-activated sodium hypochlorite with methylene blue photosensitizer
Also known as: Group-II
Mechanical activation device creating swirling motion
Continuous irrigation with negative pressure suction
Outcome 1: Bacterial Reduction
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
Time frame: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
Outcome 2: Postoperative Pain Level
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)
Time frame: 6 hours, 24 hours, 48 hours, and 7 days post-treatment
Bacterial Community Composition
Changes in bacterial diversity and species abundance via metagenomic analysis. Next-generation sequencing analysis to identify changes in bacterial species composition and microbial diversity indices.
Time frame: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
Correlation Between Bacterial Reduction and Pain
Statistical correlation coefficient between bacterial load reduction and VAS scores. Pearson or Spearman correlation analysis to evaluate relationship between irrigation efficacy and postoperative pain levels.
Time frame: Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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