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

Çukurova University

Status: Completed

Conditions: Chronic Apical Periodontitis

Treatments: Device: Passive Ultrasonic Irrigation (PUI); Device: EDDY Sonic Activation System

Study type: Interventional

Funder types: Other

Identifiers

NCT07033247

08.11.2024/149

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 6 patient groups

2.5% NaOCl - Neddle Irrigation

No Intervention group

Description:

Irrigation was performed with a 30 G side-vented needle using 2.5% sodium hypochlorite (NaOCl). A total of 11 mL NaOCl was used: 2 mL after coronal preparation, 2 mL after middle third, 2 mL after apical third preparation, and 5 mL as final irrigation. Canals were then flushed with 2 mL saline and 2 mL 17% Ethylenediaminetetraacetic Acid (EDTA).

2.5% NaOCl - EDDY Activation

Experimental group

Description:

Following 2 mL irrigation with 2.5% NaOCl, canals were activated using the EDDY sonic system (25/04 polyamide tip, 6000 Hz) 2 mm short of working length for 20 seconds, repeated 3 times. Between activations, 1 mL NaOCl was used. Total 11 mL NaOCl was delivered. Final irrigation was performed with 2 mL saline and 2 mL 17% EDTA.

Treatment:

Device: EDDY Sonic Activation System

2.5% NaOCl - Passive Ultrasonic Irrigation

Experimental group

Description:

Canals were irrigated with 2 mL 2.5% NaOCl and activated using a passive ultrasonic tip without contact with dentin walls, 2 mm short of working length for 20 seconds, repeated 3 times. Each cycle was followed by 1 mL NaOCl. Final irrigation included 2 mL saline and 2 mL 17% EDTA.

Treatment:

Device: Passive Ultrasonic Irrigation (PUI)

5.25% NaOCl - Needle Irrigation

No Intervention group

Description:

Irrigation was performed with a 30 G side-vented needle using 5.25% sodium hypochlorite. A total of 11 mL NaOCl was used as in the other groups. Final irrigation included 2 mL saline and 2 mL 17% EDTA.

5.25% NaOCl - EDDY Activation

Experimental group

Description:

Following 2 mL irrigation with 5.25% NaOCl, EDDY activation was performed (as described in Arm 2), with 1 mL NaOCl used between activations. Final irrigation was performed with 2 mL saline and 2 mL 17% EDTA.

Treatment:

Device: EDDY Sonic Activation System

5.25% NaOCl - Passive Ultrasonic Irrigation

Experimental group

Description:

After irrigation with 2 mL of 5.25% NaOCl, canals were activated using a passive ultrasonic tip (as in Arm 3), with 1 mL NaOCl used between activations. Final irrigation consisted of 2 mL saline and 2 mL 17% EDTA.

Treatment:

Device: Passive Ultrasonic Irrigation (PUI)