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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonic-Activated Irrigation | Experimental |
| |
| Passive Ultrasonic Irrigation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonic-Activated Irrigation | Device | Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece. |
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| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Effect Evaluation |
| 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | Postoperative pain was assessed using the Visual Analogue Scale (VAS) during clinical follow-up on day 1 after treatment. | day 1 after treatment |
| Cone Beam Computed Tomography Periapical Index Scores (CBCTPAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Yuee | Contact | 0086-020-62787149 | yueeliang734@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Passive Ultrasonic Irrigation | Device | Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France) |
|
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;
| 12 months after treatment |
| 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. | 12 months after treatment |