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.
Agree to participate in this study and provide informed consent;
Age 18-59 years at the time of enrolment;
At least one permanent tooth diagnosed with chronic periapical periodontitis at root development stage of Nolla10th;
Able to follow up on schedule.
Allergies to any medications or materials necessary to complete the procedures;
Non-restorable teeth, teeth with severe defects, or teeth that need to be extracted due to orthodontic treatment;
Teeth with root canal treatment or vital pulp therapy;
Teeth with canal calcification or root canal instrument separation;
Parallel
Sonic-Activated Irrigation
DeviceSonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
Passive Ultrasonic Irrigation
DevicePassive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)
Therapeutic Effect Evaluation
1. Success: A tooth is considered successfully treated when it is asymptomatic, showing no signs of apical infection such as percussion pain, mobility (loosening), tenderness, mucosal swelling, sinus tract, or fistula. Radiographically, the periapical radiolucency must demonstrate either absence or significant reduction. 2. Failure: Treatment is deemed unsuccessful if the tooth remains symptomatic or develops new symptoms of apical infection (e.g., pain, fistula). Radiographically, the size of the periapical radiolucency remains unchanged or shows enlargement.
postoperative pain
Postoperative pain was assessed using the Visual Analogue Scale (VAS) during clinical follow-up on day 1 after treatment.
Cone Beam Computed Tomography Periapical Index Scores (CBCTPAI)
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； 1. Diameter of periapical radiolucency \> 0.5-1 mm； 2. Diameter of periapical radiolucency \> 1-2 mm； 3. Diameter of periapical radiolucency \> 2-4 mm； 4. Diameter of periapical radiolucency \> 4-8 mm； 5. Diameter of periapical radiolucency \> 8 mm； Score (n) + E： Expansion of periapical cortical bone； Score (n) + D ： Destruction of periapical cortical bone.
The size of the periapical lesion
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.
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