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

Not Applicable

Completed

• Conditions: Chronic Apical Periodontitis

• Registration Number: NCT07033247
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-11
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	up to 72 hours	The 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.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Sarıçam, Turkey