NCT07546773

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

March 2, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 2, 2026

Last Update Submit

April 28, 2026

Conditions

Dental Pulp NecrosisPulpitis

Keywords

Root canal treatmentIrrigation protocolUltrasonic activationLaser activationNegative pressure irrigationMechanical activationMetagenomic analysisPostoperative painVisual analogue scaleBacterial reductionEndodonticsPulpSuckerEasy clean deviceNext generation sequencing

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Bacterial Community Composition

    Pre-irrigation (baseline "Day-1") to post-irrigation "Day-1" after irrigation)

  • Correlation Between Bacterial Reduction and Pain

    Post-irrigation bacterial analysis correlated with pain scores at 6 hours, 24 hours, 48 hours, and 7 days

Study Arms (4)

Ultrasonic Activation

EXPERIMENTAL

Root canals will be irrigated with sodium hypochlorite (NaOCl) activated using an ultrasonic device (Ultramint with R17 tip).

Procedure: Ultrasonic Irrigation Activation

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.

Procedure: Laser-Activated Irrigation

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.

Procedure: Mechanical Irrigation Activation

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.

Procedure: Negative Pressure Irrigation

Interventions

Ultrasonic Irrigation ActivationPROCEDURE

Sodium hypochlorite irrigation activated with ultrasonic device

Also known as: Group-I
Ultrasonic Activation
Laser-Activated IrrigationPROCEDURE

Laser-activated sodium hypochlorite with methylene blue photosensitizer

Also known as: Group-II
ARM 2: Laser Activation
Mechanical Irrigation ActivationPROCEDURE

Mechanical activation device creating swirling motion

ARM 3: Mechanical Activation (Easy Clean)
Negative Pressure IrrigationPROCEDURE

Continuous irrigation with negative pressure suction

ARM 4: Negative Pressure Irrigation (PulpSucker)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontic Clinic, Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

Location

MeSH Terms

Conditions

Dental Pulp NecrosisPulpitisPain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Salma Mohamed Hassan Gohar, MSc

CONTACT

0020 1157445565Salma_gohar@dent.suez.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer, Department of Endodontics

Study Record Dates

First Submitted

March 2, 2026

First Posted

April 23, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

January 15, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

EG(1)