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| ID | Type | Description | Link |
|---|---|---|---|
| REC 928/2024 | Registry Identifier | Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic Activation | Experimental | Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip). |
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| ARM 2: Laser Activation | Experimental | 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. |
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| ARM 3: Mechanical Activation (Easy Clean) | Experimental | Root canals will be irrigated with NaOCl, activated mechanically using the Easy Clean device (BassiEndo) to create a swirling motion for improved disinfection. |
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| ARM 4: Negative Pressure Irrigation (PulpSucker) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Irrigation Activation | Procedure | Sodium hypochlorite irrigation activated with ultrasonic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 6 hours, 24 hours, 48 hours, and 7 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salma Mohamed Hassan Gohar, MSc | Contact | 0020 1157445565 | Salma_gohar@dent.suez.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Salah El-Din Mohamed Abdallah, Professor, PhD | Professor of Microbiology, Faculty of Pharmacy, Suez Canal University | Study Director |
| Hayam Youssef Hassan, Professor, PhD | Professor of Endodontics, Faculty of Dentistry, Suez Canal University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endodontic Clinic, Faculty of Dentistry, Suez Canal University | Ismailia | Ismailia Governorate | 41522 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 25, 2025 |
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Single (Outcomes Assessor) Explanation: Patients and clinician cannot be blinded to irrigation method, but laboratory personnel analyzing bacterial samples and statisticians can be blinded to group allocation.
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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
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| Laser-Activated Irrigation | Procedure | Laser-activated sodium hypochlorite with methylene blue photosensitizer |
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| Mechanical Irrigation Activation | Procedure | Mechanical activation device creating swirling motion |
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| Negative Pressure Irrigation | Procedure | Continuous irrigation with negative pressure suction |
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| 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. |
| Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days |
| Apr 10, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 25, 2025 | Apr 28, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D011671 | Pulpitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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