Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis
NCT ID: NCT07069881
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-12-30
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sonic-Activated Irrigation
Sonic-Activated Irrigation
Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
Passive Ultrasonic Irrigation
Passive Ultrasonic Irrigation
Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)
Interventions
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Sonic-Activated Irrigation
Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.
Passive Ultrasonic Irrigation
Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)
Eligibility Criteria
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Inclusion Criteria
2. Age 18-59 years at the time of enrolment;
3. At least one permanent tooth diagnosed with chronic periapical periodontitis at root development stage of Nolla10th;
4. Able to follow up on schedule.
Exclusion Criteria
2. Non-restorable teeth, teeth with severe defects, or teeth that need to be extracted due to orthodontic treatment;
3. Teeth with root canal treatment or vital pulp therapy;
4. Teeth with canal calcification or root canal instrument separation;
5. Teeth with root fracture or vertical root fracture;
6. Tooth with internal or external root resorption;
7. Patients with periodontitis;
8. Patients with orthodontic treatment;
9. Presence of dental phobia;
10. Women who are pregnant;
11. Patients who have taken medications that affect central nervous system, such as tricyclic antidepressant;
12. Patients who have taken medications that affect immune response, such as glucocorticoid or cyclosporin;
13. Patients after radiotherapy of tumor head and neck;
14. Patients who have taken medications that affect curative effect, such as bisphosphonates;
15. Patients with serious systemic diseases that can affect curative effect;
16. Participation in other clinical studies within the past several weeks;
17. Patients who are deemed unsuitable to participate in the study by investigators.
18 Years
59 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Southern Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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NFEC-2024-435
Identifier Type: -
Identifier Source: org_study_id
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