Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07546773

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dental Pulp Necrosis Dental Pulp Diseases Necrosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulpitis Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endodontic Clinic, Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Location contact

Hayam Youssef Hassan, Professor, PhD

CONTACT

+20 1227609611

Salma Mohamed Hassan Gohar, MSc

CONTACT

[email protected]

00201157445565

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic Irrigation Activation

Procedure

Sodium hypochlorite irrigation activated with ultrasonic device

Other names: Group-I

Laser-Activated Irrigation

Procedure

Laser-activated sodium hypochlorite with methylene blue photosensitizer

Other names: Group-II

Mechanical Irrigation Activation

Procedure

Mechanical activation device creating swirling motion

Negative Pressure Irrigation

Procedure

Continuous irrigation with negative pressure suction

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Salma Mohamed Hassan Gohar, MSc

CONTACT

[email protected]

0020 1157445565

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.