Evaluation of Different Root Canal Irrigation Techniques

NCT ID: NCT07106320

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2025-06-01

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.

Detailed Description

Root canal treatment aims to eliminate microorganisms and their byproducts from the complex root canal system to allow periapical tissue healing. Due to the anatomical complexity of root canals-such as isthmuses, apical deltas, and lateral canals-mechanical preparation alone is often insufficient. Therefore, chemical irrigation plays a vital role in successful disinfection.

This randomized clinical trial investigates the influence of three different irrigation protocols on postoperative pain and periapical healing in permanent premolar and molar teeth with radiographically evident apical periodontitis (Periapical Index (PAI) score 4-5).

The study includes three experimental groups :

Group 1 (Sonic activation): Irrigation solution is activated using the EDDY sonic tip.

Group 2 (Ultrasonic activation): Irrigation is activated using VDW Ultra ultrasonic tips.

Group 3 (Control): Conventional needle irrigation is performed without activation.

All treatments will be performed under rubber dam isolation and local anesthesia, using a standardized instrumentation protocol with ProTaper Next rotary files. Between each file change, the root canal will be irrigated with 5 ml of 3% sodium hypochlorite (NaOCl). The final irrigation protocol will be applied according to the assigned group. All endodontic procedures will be completed in a single session.

Postoperative pain levels will be assessed using both the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) scales at 6, 12, 18, 24, 48, and 72 hours, as well as on day 7 and at 1 month. Patients will be asked to record analgesic consumption (400 mg ibuprofen as needed) and will submit pain diaries.

One year after treatment, periapical healing will be evaluated using periapical radiography (parallel technique) by two blinded observers.

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Conditions

Apical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasonic Irrigation Activation (VDW Ultra)

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.

Group Type: EXPERIMENTAL

VDW Ultra Ultrasonic Irrigation Activation

Intervention Type: 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.

Sonic Irrigation Activation (EDDY)

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.

Group Type: EXPERIMENTAL

EDDY Sonic Irrigation Activation

Intervention Type: 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.

Conventional Irrigation (Control)

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.

Group Type: ACTIVE_COMPARATOR

Conventional Needle Irrigation

Intervention Type: 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.

Interventions

VDW Ultra Ultrasonic Irrigation Activation

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.

Intervention Type: DEVICE

EDDY Sonic Irrigation Activation

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.

Intervention Type: DEVICE

Conventional Needle Irrigation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

ASLI USTA TAHMAZ

Principal Investigator, Department of Endodontics, Medipol University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-6497

Identifier Type: -

Identifier Source: org_study_id