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)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
Inclusion Criteria:
1. Agree to participate in this study and provide informed consent;
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:
1. Allergies to any medications or materials necessary to complete the procedures;
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.
Primary outcome measure(s)
Therapeutic Effect Evaluation — 12 months after treatment 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.
Trial sites (1)
Facility
City
Region
Status
Southern Hospital, Southern Medical University
Guangzhou
Guangdong
Recruiting
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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