Evaluation of Different Root Canal Irrigation Techniques

NCT07106320 | Completed

• 1 other identifier: E-10840098-772.02-6497
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). A total of 162 patients are randomly assigned to one of three groups: (1) sonic irrigation activation using EDDY, (2) ultrasonic irrigation activation using VDW Ultra, and (3) conventional syringe irrigation as the control. Postoperative pain will be recorded using the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) at multiple time points up to one month. Periapical healing will be assessed using periapical imaging performed with the parallel technique one year after treatment. The study aims to determine whether enhanced irrigation techniques provide superior clinical outcomes compared to traditional methods.

Conditions

Apical Periodontitis

Keywords

Irrigation activation; Sonic activation; Ultrasonic activation; Apical periodontitis; Periapical Healing; Post operative pain

Outcome Measures

Primary Outcomes (1)

• Periapical Healing

  The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).

  From end of treatment to 1 year

Secondary Outcomes (1)

• Postoperative Pain Intensity - Visual Analog Scale

  From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment

Other Outcomes (1)

• Post Operative Pain İntensity

  From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal treatment

Study Arms (3)

Ultrasonic Irrigation Activation (VDW Ultra)

EXPERIMENTAL

Irrigation will be activated using an ultrasonic device (VDW Ultra) with an IRRI S tip positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated ultrasonically for 20seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions.

Device: VDW Ultra Ultrasonic Irrigation Activation

Sonic Irrigation Activation (EDDY)

EXPERIMENTAL

Irrigation will be activated using a sonic device (EDDY tip, VDW) positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated for 20 seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions.

Device: EDDY Sonic Irrigation Activation

Conventional Irrigation (Control)

ACTIVE COMPARATOR

Irrigation will be performed using a syringe and needle without activation. Final irrigation will be performed using conventional syringe and needle irrigation without any activation. Each canal will be irrigated with 6 mL of 3% Sodium Hypochlorite (NaOCl), followed by 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) and 5 mL of sterile saline, using a side-vented needle.

Procedure: Conventional Needle Irrigation

Interventions

VDW Ultra Ultrasonic Irrigation Activation DEVICE

Irrigation will be activated using an ultrasonic tip (IRRI S 21/25) connected to the VDW Ultra device (VDW GmbH, Munich, Germany), 2 mm short of working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.

Ultrasonic Irrigation Activation (VDW Ultra)

EDDY Sonic Irrigation Activation DEVICE

Irrigation solution will be activated using the EDDY sonic tip (VDW GmbH, Munich, Germany), positioned 2 mm short of the working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.

Sonic Irrigation Activation (EDDY)

Conventional Needle Irrigation PROCEDURE

Irrigation will be performed using a syringe and needle without activation. A total of 6 ml NaOCl, 2 ml EDTA and 5 mL of sterile saline will be used during final irrigation.

Conventional Irrigation (Control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Premolar and molar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
• Systemically healthy individuals
• To be able to read and sign the informed consent form
• Physical and mental fitness to undergo treatment
• Willingness to attend all follow-up sessions

You may not qualify if:

• Patients with systemic diseases classified as ASA III or higher
• Presence of severe periodontal disease (probing depth \>4 mm)
• Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Endodontics, Medipol University

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: August 6, 2025
• Study Start: November 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared starting 6 months after publication.
• Access Criteria: Qualified researchers may request access to all de-identified individual participant data (IPD) and study protocols. Access will be granted upon reasonable request by contacting the corresponding author via email and after signing a data sharing agreement

Locations

TU (1)