Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis

NCT07069881 | Recruiting

• 1 other identifier: NFEC-2024-435
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Therapeutic Effect Evaluation

  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.

  12 months after treatment

Secondary Outcomes (3)

• postoperative pain

  day 1 after treatment

• Cone Beam Computed Tomography Periapical Index Scores (CBCTPAI)

  12 months after treatment

• The size of the periapical lesion

  12 months after treatment

Study Arms (2)

Sonic-Activated Irrigation

EXPERIMENTAL

Device: Sonic-Activated Irrigation

Passive Ultrasonic Irrigation

ACTIVE COMPARATOR

Device: Passive Ultrasonic Irrigation

Interventions

Sonic-Activated Irrigation DEVICE

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

Sonic-Activated Irrigation

Passive Ultrasonic Irrigation DEVICE

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

Passive Ultrasonic Irrigation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Agree to participate in this study and provide informed consent;
• Age 18-59 years at the time of enrolment;
• At least one permanent tooth diagnosed with chronic periapical periodontitis at root development stage of Nolla10th;
• Able to follow up on schedule.

You may not qualify if:

• Allergies to any medications or materials necessary to complete the procedures;
• Non-restorable teeth, teeth with severe defects, or teeth that need to be extracted due to orthodontic treatment;
• Teeth with root canal treatment or vital pulp therapy;
• Teeth with canal calcification or root canal instrument separation;
• Teeth with root fracture or vertical root fracture;
• Tooth with internal or external root resorption;
• Patients with periodontitis;
• Patients with orthodontic treatment;
• Presence of dental phobia;
• Women who are pregnant;
• Patients who have taken medications that affect central nervous system, such as tricyclic antidepressant;
• Patients who have taken medications that affect immune response, such as glucocorticoid or cyclosporin;
• Patients after radiotherapy of tumor head and neck;
• Patients who have taken medications that affect curative effect, such as bisphosphonates;
• Patients with serious systemic diseases that can affect curative effect;

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Central Study Contacts

Liang Yuee

CONTACT

0086-020-62787149; yueeliang734@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 17, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CN (1)