Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis (SONIC-ULTRA)

Comparison of Sonic and Ultrasonic Activation of Irrigation Solutions on the Healing of Teeth With Apical Periodontitis

The goal of this clinical trial is to learn whether two different irrigation activation methods - passive ultrasonic irrigation (PUI) and sonic activation - help periapical healing in root canal treatments of single-rooted teeth with apical periodontitis.

Researchers will also compare these methods with the traditional needle irrigation technique.

The main questions this study aims to answer are

Do sonic irrigation activation or PUI activation methods lead to faster or better early periapical healing compared with traditional needle irrigation?

Is there any difference in healing volume measured by cone-beam computed tomography (CBCT) after 6 months?

Participants in this study will:

Adults with single-rooted teeth showing apical periodontitis (PAI ≥ 3),

Receive root canal treatment using either PUI, sonic activation, or traditional needle irrigation (assigned randomly).

Participants will have CBCT scans before treatment and again at 6 months to measure changes in lesion volume.

Researchers will analyze the 3D images using specialized software to calculate periapical lesion volumes before and after treatment. The study will evaluate how much the lesion size decreases in each group and whether any activation method improves healing compared with standard irrigation.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis
• Intervention / Treatment: Procedure: Sonic Activation Irrigation; Procedure: Passive Ultrasonic Irrigation (PUI); Procedure: Conventional Needle Irrigation

Detailed Description

Apical periodontitis (AP) develops as a consequence of pulpal infection and the subsequent host inflammatory response. The success of root canal treatment depends greatly on eliminating intraradicular biofilm and preventing reinfection. Adjunctive activation of irrigants-such as sonic or passive ultrasonic irrigation-has been proposed to enhance irrigant penetration, debris removal, and overall microbial disruption compared with conventional needle irrigation. This randomized, three-armed, parallel clinical trial evaluates whether sonic or ultrasonic activation of irrigating solutions leads to superior early periapical healing in single-rooted teeth diagnosed with AP. The study is based on the biological premise that activation improves irrigant replacement dynamics, acoustic streaming, and penetration into anatomically complex spaces that standard needle irrigation may not adequately reach. All participants received standardized root canal treatment using contemporary instrumentation, irrigation solutions, and obturation materials. The three intervention groups differed only in the method used to activate irrigants during the final cleaning phase. This uniformity ensured that any differences in healing outcomes reflect the effect of activation rather than variations in clinical technique. Early healing was assessed volumetrically using cone-beam computed tomography (CBCT), which enables three-dimensional visualization of periapical tissues and provides a sensitive measure of lesion change over time. Volumetric analysis was performed with a predefined workflow to ensure reproducibility, including blinded assessment to minimize bias. The study focuses on quantifying the reduction in periapical lesion volume at 6 months and exploring whether sonic or ultrasonic activation offers measurable advantages in early tissue healing compared with conventional irrigation. The findings aim to contribute to evidence-based endodontic protocols, particularly regarding the role of adjunctive activation techniques in improving periapical healing following root canal treatment.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34303
    • Istanbul Aydın University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:• American Society of Anesthesiologists physical status classification system (ASA) class I and II

• Individuals between 13 and 65 years of age
• Good oral hygiene

Tooth-related:

• Single-rooted teeth
• Sufficient amount of coronal tooth structure
• Probing depth of ≤ 4 mm
• Presence of Apical periodontitis (AP) on radiographs
• Asymptomatic teeth
• Periapical Index (PAI) score ≥ 3
• Negative response to pulp vitality tests
• Mature teeth

Exclusion Criteria:• ASA class III or higher

• Pregnancy or lactation
• Individuals with mental retardation
• Allergy to Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), or latex

Tooth-related:

• Extensive structural loss that cannot be restored with a filling
• Presence of subgingival caries
• Teeth previously treated with root canal therapy
• Fractured or cracked teeth due to trauma
• Non-vital teeth without radiographic evidence of AP
• Immature teeth
• Positive response to pulp vitality tests
• Presence of internal or external root resorption detected on radiographs
• Increased mobility due to insufficient bone support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonic Activation; Sonic irrigation activation using Micron TA-200 with EDDY tips	Procedure: Sonic Activation Irrigation; Root canal irrigation activated sonically using EDDY tips (25/.04, VDW GmbH, Munich, Germany) attached to the Micron TA-200 sonic device. The tip was positioned 2 mm short of the WL. Sodium hypochlorite (2.5%), EDTA (17%), and chlorhexidine (2%) solutions were sequentially activated according to the study protocol.
Experimental: Ultrasonic Activation (PUI); Passive ultrasonic irrigation using Ultra X activator	Procedure: Passive Ultrasonic Irrigation (PUI); Irrigation activation performed with an ultrasonic activator (Ultra X, Eighteeth, China) using 21 mm silver tips with 2% taper. The tip was positioned 2 mm short of the WL. Sodium hypochlorite (2.5%), EDTA (17%), and chlorhexidine (2%) were activated sequentially following the standardized protocol.
Active Comparator: Conventional Needle Irrigation (Control); Manual syringe irrigation using a 30-gauge side-vented needle	Procedure: Conventional Needle Irrigation; Manual syringe irrigation performed using a 30-gauge side-vented needle inserted 1 mm short of the WL. The canals were irrigated sequentially with sodium hypochlorite (2.5%), EDTA (17%), and chlorhexidine (2%) without any activation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Title: Change in Apical Lesion Volume Measured by Cone-Beam Computed Tomography (CBCT)	Volumetric change of apical periodontitis (AP) lesions in single-rooted teeth between baseline (pre-treatment) and 6-month follow-up, measured using 3D Doctor software on CBCT scans (Morita 3D Accuitomo 170). The measurement unit is cubic millimeters (mm³). Outcome Type: Continuous (quantitative) Statistical Method: Wilcoxon signed-rank test for within-group comparison; Kruskal-Wallis test for between-group analysis.	Baseline to 6 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Reduction in Apical Lesion Volume	Percent change (%) in lesion volume between baseline and 6-month follow-up, representing the proportion of lesion reduction relative to the initial volume. Healing is classified as complete (100%), partial (>25%), or uncertain (<25%) based on CBCT volumetric analysis.	Baseline to 6 months post-treatment
Radiographic Healing Status	Qualitative classification of periapical healing on CBCT and digital periapical radiographs into: complete healing (normal periodontal ligament space),; partial healing (volume reduction),; uncertain healing (<25% reduction),; no healing or increased lesion size.	6 months post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events During and After Treatment	Number and type of clinical complications during or after endodontic treatment (flare-ups, swelling, restoration loss, or tooth fracture).	Throughout treatment and follow-up period (baseline to 6 months)

Collaborators and Investigators

• Sponsor: Hilal Çuhadar Beşiroğlu
• Investigators: Study Director: Işıl Kaya Büyükbayram, DDS, PhD, Istanbul Aydın University, Faculty of Dentistry, Department of Endodontics; Principal Investigator: Hilal Cuhadar Besiroglu, DDS, Istanbul Aydın University, Faculty of Dentistry Department of Endodontics

Publications and helpful links

General Publications

• Dogan MU, Aricioglu B, Kose TE, Cikman AS, Oksuzer MC. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376. doi: 10.1007/s00784-024-05758-4.
• Arikan NS, Hepsenoglu YE, Ersahan S, Ozcelik F. Periradicular repair after single-visit root canal treatment using sonic irrigant activation of teeth with apical periodontitis. Clin Oral Investig. 2024 Nov 26;28(12):656. doi: 10.1007/s00784-024-06059-6.

Helpful Links

• Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): March 12, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Apical Periodontitis; Periapical Healing; Sonic Activation; Passive Ultrasonic Activation
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: 2022/164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results will be shared upon reasonable request after publication, with investigators who provide a methodologically sound proposal approved by the ethics committee. Data will be available through the institutional repository of Istanbul Aydın University.
• IPD Sharing Time Frame: The de-identified IPD and supporting documents (Study Protocol and Statistical Analysis Plan) will be available beginning 6 months after publication of the primary results and ending 3 years thereafter.
• IPD Sharing Access Criteria: Qualified researchers who provide a methodologically sound proposal approved by the institutional ethics committee may request access to the de-identified individual participant data (IPD) and supporting documents, including the study protocol and statistical analysis plan. Access will be granted through the secure institutional repository of Istanbul Aydın University after signing a data use agreement to ensure confidentiality and proper data handling.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No