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

ConditionsDental Pulp NecrosisPulpitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSuez Canal University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with open apices

Severe periodontal disease

Currently taking antibiotics

Allergy to study materials (lidocaine, sodium hypochlorite, methylene blue, latex)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasonic Irrigation Activation

    Procedure/Surgery

    Sodium hypochlorite irrigation activated with ultrasonic device

  • Laser-Activated Irrigation

    Procedure/Surgery

    Laser-activated sodium hypochlorite with methylene blue photosensitizer

  • Mechanical Irrigation Activation

    Procedure/Surgery

    Mechanical activation device creating swirling motion

  • Negative Pressure Irrigation

    Procedure/Surgery

    Continuous irrigation with negative pressure suction

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Ultrasonic ActivationExperimental treatment 1 intervention
Group B: ARM 2: Laser ActivationExperimental treatment 1 intervention
Group C: ARM 3: Mechanical Activation (Easy Clean)Experimental treatment 1 intervention
Group D: ARM 4: Negative Pressure Irrigation (PulpSucker)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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

Secondary outcomes

1

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)
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: