NCT07106320

Evaluation of Different Root Canal Irrigation Techniques

Evaluation of the Effect of Different Root Canal Irrigation Techniques on Periapical Tissue Healing and Postoperative Pain in Teeth With Apical Periodontitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). A total of 162 patients are randomly assigned to one of three groups: (1) sonic irrigation activation using EDDY, (2) ultrasonic irrigation activation using VDW Ultra, and (3) conventional syringe irrigation as the control. Postoperative pain will be recorded using the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) at multiple time points up to one month. Periapical healing will be assessed using periapical imaging performed with the parallel technique one year after treatment. The study aims to determine whether enhanced irrigation techniques provide superior clinical outcomes compared to traditional methods.

Detailed description

Root canal treatment aims to eliminate microorganisms and their byproducts from the complex root canal system to allow periapical tissue healing. Due to the anatomical complexity of root canals-such as isthmuses, apical deltas, and lateral canals-mechanical preparation alone is often insufficient. Therefore, chemical irrigation plays a vital role in successful disinfection. This randomized clinical trial investigates the influence of three different irrigation protocols on postoperative pain and periapical healing in permanent premolar and molar teeth with radiographically evident apical periodontitis (Periapical Index (PAI) score 4-5). The study includes three experimental groups : Group 1 (Sonic activation): Irrigation solution is activated using the EDDY sonic tip. Group 2 (Ultrasonic activation): Irrigation is activated using VDW Ultra ultrasonic tips. Group 3 (Control): Conventional needle irrigation is performed without activation. All treatments will be performed under rubber dam isolation and local anesthesia, using a standardized instrumentation protocol with ProTaper Next rotary files. Between each file change, the root canal will be irrigated with 5 ml of 3% sodium hypochlorite (NaOCl). The final irrigation protocol will be applied according to the assigned group. All endodontic procedures will be completed in a single session. Postoperative pain levels will be assessed using both the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) scales at 6, 12, 18, 24, 48, and 72 hours, as well as on day 7 and at 1 month. Patients will be asked to record analgesic consumption (400 mg ibuprofen as needed) and will submit pain diaries. One year after treatment, periapical healing will be evaluated using periapical radiography (parallel technique) by two blinded observers. .

Conditions

• Apical Periodontitis

Interventions

Type	Name	Description
DEVICE	VDW Ultra Ultrasonic Irrigation Activation	Irrigation will be activated using an ultrasonic tip (IRRI S 21/25) connected to the VDW Ultra device (VDW GmbH, Munich, Germany), 2 mm short of working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.
DEVICE	EDDY Sonic Irrigation Activation	Irrigation solution will be activated using the EDDY sonic tip (VDW GmbH, Munich, Germany), positioned 2 mm short of the working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.
PROCEDURE	Conventional Needle Irrigation	Irrigation will be performed using a syringe and needle without activation. A total of 6 ml NaOCl, 2 ml EDTA and 5 mL of sterile saline will be used during final irrigation.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-08-06
• Last updated: 2025-08-06

Locations

1 site across 1 country: Turkey (Türkiye)