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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5% NaOCl - Neddle Irrigation | No Intervention | 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 | 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. |
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| 2.5% NaOCl - Passive Ultrasonic Irrigation | Experimental | 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. |
|
| 5.25% NaOCl - Needle Irrigation | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDDY Sonic Activation System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | 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. | up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koray Yılmaz, DDS MSc | Cukurova University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | Sarıçam | 01250 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35267110 | Background | Erkan E, Gundogar M, Uslu G, Ozyurek T. Postoperative pain after SWEEPS, PIPS, sonic and ultrasonic-assisted irrigation activation techniques: a randomized clinical trial. Odontology. 2022 Oct;110(4):786-794. doi: 10.1007/s10266-022-00700-0. Epub 2022 Mar 10. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 5.25% NaOCl - EDDY Activation | Experimental | 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. |
|
| 5.25% NaOCl - Passive Ultrasonic Irrigation | Experimental | 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. |
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| Passive Ultrasonic Irrigation (PUI) | Device | 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. |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |