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

April 28, 2026 updated by: Salma gohar, Suez Canal University

Metagenomic Analysis and Post-operative Pain Assessment of Infected Root Canals Using Different Irrigation Protocols: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypt, 41522
        • Endodontic Clinic, Faculty of Dentistry, Suez Canal University
        • Contact:
        • Contact:
          • Hayam Youssef Hassan, Professor, PhD
          • Phone Number: +20 1227609611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonic Activation
Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip).
Procedure: Ultrasonic Irrigation Activation
Sodium hypochlorite irrigation activated with ultrasonic device
Other Names:
  • Group-I
Experimental: ARM 2: Laser 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
Laser-activated sodium hypochlorite with methylene blue photosensitizer
Other Names:
  • Group-II
Experimental: ARM 3: Mechanical Activation (Easy Clean)
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
Mechanical activation device creating swirling motion
Experimental: ARM 4: Negative Pressure Irrigation (PulpSucker)
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
Continuous irrigation with negative pressure suction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome 1: Bacterial Reduction
Time Frame: 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
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial Community Composition
Time Frame: Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)
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)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Director: Salah El-Din Mohamed Abdallah, Professor, PhD, Professor of Microbiology, Faculty of Pharmacy, Suez Canal University
  • Study Chair: Hayam Youssef Hassan, Professor, PhD, Professor of Endodontics, Faculty of Dentistry, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

January 15, 2028

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC 928/2024 (Registry Identifier: Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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