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The Effect of Different Sodium Hypochlorite Concentrations and Activation Techniques on Postoperative Pain

The Effect of Different Sodium Hypochlorite Concentrations and Activation Techniques on Postoperative Pain in Permanent Molars With Chronic Apical Periodontitis: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07033247
Enrollment
120
Registered
2025-06-24
Start date
2024-12-11
Completion date
2025-04-27
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Apical Periodontitis

Keywords

Sodium hypochlorite, Chronic apical periodontitis, Postoperative pain, Irrigation activation, Passive ultrasonic irrigation

Brief summary

The goal of this clinical trial was to evaluate the effect of different sodium hypochlorite (NaOCl) concentrations and irrigation activation techniques on the intensity of postoperative pain following single-visit root canal treatment in molar teeth with asymptomatic chronic apical periodontitis. The primary research questions of this study were as follows: Does using 2.5% or 5.25% sodium hypochlorite solution during root canal irrigation influence the severity of postoperative pain? Do activation techniques such as sonic activation using EDDY (a flexible polyamide tip-driven sonic irrigation device operating at 6,000 Hz; VDW GmbH, Munich, Germany) or passive ultrasonic irrigation (PUI) significantly reduce postoperative pain compared to conventional needle irrigation? In the non-activation groups, root canals were irrigated with 2.5% or 5.25% NaOCl using a 30-gauge side-vented needle without any further activation. In the EDDY groups, root canals were irrigated using 2.5% or 5.25% NaOCl, followed by activation with a flexible polyamide EDDY tip (25/04) at 6,000 Hz, three times for 20 seconds. In the PUI groups, root canals were irrigated using 2.5% or 5.25% NaOCl, and then subjected to passive ultrasonic activation with a suitable ultrasonic tip three times for 20 seconds, without contacting dentinal walls.

Interventions

DEVICEEDDY Sonic Activation System

EDDY is a sonic irrigation activation system operating at 6,000 Hz frequency with a flexible polyamide tip (25/04). In endodontic procedures, the EDDY tip is inserted 2 mm short of the working length into the root canal and activated for 20 seconds in three consecutive cycles. The sonic activation enhances irrigant agitation through cavitation and acoustic streaming, improving cleaning efficacy within the root canal system, especially in curved canals. The device does not contact dentin walls, reducing the risk of iatrogenic damage. In this study, EDDY was used to activate sodium hypochlorite solutions of either 2.5% or 5.25% concentration depending on the assigned group.

Passive Ultrasonic Irrigation (PUI) involves the use of an ultrasonically activated file or tip inserted into the root canal 2 mm short of the working length, without contacting the dentinal walls. The ultrasonic tip is operated in a non-cutting, passive manner to generate acoustic streaming and cavitation within the irrigant. In this study, after initial irrigation with 2 mL of sodium hypochlorite (either 2.5% or 5.25%, depending on the group), ultrasonic activation was performed for 20 seconds in three consecutive cycles. Each activation was followed by 1 mL NaOCl irrigation. This method is designed to enhance the penetration and effectiveness of irrigants, especially in anatomically complex areas of the root canal system.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged between 16 and 60 years * Systemically healthy individuals * Presence of mandibular or maxillary first or second molar diagnosed with asymptomatic chronic apical periodontitis * Negative response to electric pulp test, cold test, percussion and palpation tests * Teeth eligible for single-visit root canal treatment * Patients who provided written informed consent

Exclusion criteria

* Pregnant or breastfeeding individuals * Patients with uncontrolled systemic diseases (e.g., uncontrolled hypertension, uncontrolled diabetes mellitus, chronic renal failure, hematologic disorders) * Patients undergoing chemotherapy or radiotherapy * Individuals with infective endocarditis or immunosuppressive conditions * Patients requiring antibiotic prophylaxis prior to dental treatment * Use of anti-inflammatory or analgesic medications within 24 hours before treatment * Teeth with calcified canals, internal/external resorption, or root fractures * Patients unable to attend follow-up appointments or complete pain assessment forms

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)up to 72 hoursThe visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026