Southern Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
NCT Number: NCT07069881
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.
Interested in participating?
Request Info18 year–59 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)
Time frame: 12 months after treatment
Time frame: day 1 after treatment
Postoperative pain was assessed using the Visual Analogue Scale (VAS) during clinical follow-up on day 1 after treatment.
Time frame: 12 months after treatment
The CBCT Periapical Index (CBCTPAI) assigns scores to lesions of chronic apical periodontitis based on the largest dimension measured in three planes (buccopalatal, mesiodistal, diagonal) on CBCT scans.
0: Intact periapical bone structures;
Time frame: 12 months after treatment
The size in periapical lesions were quantified using cone beam computed tomography (CBCT) at 1-year postoperative compared to preoperative baseline across three anatomical planes: buccopalatal, mesiodistal, and diagonal.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
A Randomized Controlled Trial of Endodontic Treatment Using Sonic-activated Irrigation and Passive Ultrasonic Irrigation to Evaluate Healing in Chronic Apical Periodontitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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