Clinical Trials Directory

Trials / Completed

CompletedNCT07033247

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
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Cukurova University · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEEDDY Sonic Activation SystemEDDY 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.
DEVICEPassive Ultrasonic Irrigation (PUI)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.

Timeline

Start date
2024-12-11
Primary completion
2025-03-25
Completion
2025-04-27
First posted
2025-06-24
Last updated
2025-06-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07033247. Inclusion in this directory is not an endorsement.