NCT07069881

Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis

A Randomized Controlled Trial of Endodontic Treatment Using Sonic-activated Irrigation and Passive Ultrasonic Irrigation to Evaluate Healing in Chronic Apical Periodontitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of Sonically Activated Irrigation (SAI) versus Passive Ultrasonic Irrigation (PUI) in the root canal treatment of teeth with chronic apical periodontitis, analyze potential influencing factors, and thereby identify a highly effective and safe root canal irrigation protocol. The ultimate goal is to provide an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.

Detailed description

Root canal therapy (RCT) is the common treatment for chronic apical periodontitis. Successful outcomes critically depend on the complete eradication of infection within the root canal system. The efficacy of infection control is significantly influenced by the irrigation technique employed. While passive ultrasonic irrigation (PUI) is a widely utilized form of activated irrigation in clinical practice, it carries inherent risks such as instrument separation and unnecessary dentin removal, limiting its use. Sonically activated irrigation (SAI) represents a novel irrigation approach. Its polymeric tips circumvent the drawbacks associated with ultrasonic metal tips while delivering comparable irrigation efficiency. However, high-quality randomized controlled clinical evidence supporting its use is currently lacking. This randomized, controlled, double-blinded clinical trial aims to directly compare the efficacy of SAI versus PUI in root canal treatment of teeth with chronic apical periodontitis and analyze potential influencing factors. The goal is to identify a highly effective and safe root canal irrigation protocol, ultimately providing an evidence-based rationale for optimizing irrigation technique selection and overall treatment strategies for chronic apical periodontitis.

Conditions

• Chronic Apical Periodontitis

Interventions

Type	Name	Description
DEVICE	Sonic-Activated Irrigation	Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
DEVICE	Passive Ultrasonic Irrigation	Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: China