Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis

NCT ID: NCT07069881

Last Updated: 2025-07-17

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sonic-Activated Irrigation

Group Type EXPERIMENTAL

Sonic-Activated Irrigation

Intervention Type DEVICE

Sonic-activated irrigation was performed using the polymer tip (Eddy™, VDW, Germany) activated by an airscaler handpiece.

Passive Ultrasonic Irrigation

Group Type ACTIVE_COMPARATOR

Passive Ultrasonic Irrigation

Intervention Type DEVICE

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.

Intervention Type DEVICE

Passive Ultrasonic Irrigation

Passive ultrasonic irrigation was performed using the ultrasonic tip (ACTEON, France) attached to an ultrasonic device (P5 Newton™, ACTEON, France)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southern Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liang Yuee

Role: CONTACT

0086-020-62787149

Other Identifiers

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NFEC-2024-435

Identifier Type: -

Identifier Source: org_study_id

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