Sonic versus passive ultrasonic irrigation for chronic root canal infection

A Randomized Controlled Trial of Endodontic Treatment Using Sonic-activated Irrigation and Passive Ultrasonic Irrigation to Evaluate Healing in Chronic Apical Periodontitis

This trial will test whether sonic-activated irrigation or passive ultrasonic irrigation cleans infected root canals better in adults with chronic apical periodontitis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07069881 on ClinicalTrials.gov

What this trial studies

This randomized, controlled, double-blinded trial compares sonically activated irrigation (SAI) with passive ultrasonic irrigation (PUI) during root canal treatment for teeth with chronic apical periodontitis. Adults aged 18–59 with a permanent tooth at Nolla stage 10 will be randomized to receive RCT using either SAI or PUI and followed on a set schedule. Primary outcomes include infection control, clinical healing, and radiographic resolution, and secondary outcomes include procedure-related complications such as instrument separation and dentin removal. The study will also analyze factors that might influence outcomes to recommend a safe, effective irrigation protocol.

Who should consider this trial

Good fit: Adults aged 18–59 with at least one permanent tooth diagnosed with chronic apical periodontitis (Nolla stage 10), who can provide informed consent and attend follow-up visits, are ideal candidates.

Not a fit: Patients who are pregnant, have periodontitis, non-restorable teeth, prior root canal treatment on the affected tooth, root fractures, canal calcification or instrument separation, ongoing orthodontic treatment, dental phobia, or contraindicating medications are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify a safer and more effective irrigation method that improves infection clearance and reduces procedural complications during root canal treatment.

How similar studies have performed: Passive ultrasonic irrigation is widely used in practice, but high-quality randomized clinical evidence supporting sonically activated irrigation is currently limited, so this direct comparison addresses a gap in evidence.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Southern Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Liang Yuee

Conditions Chronic Apical Periodontitis