Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis
SONIC-ULTRA
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2025
CompletedFirst Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedDecember 11, 2025
December 1, 2025
2 years
November 18, 2025
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Percentage Reduction in Apical Lesion Volume
Baseline to 6 months post-treatment
Radiographic Healing Status
6 months post-treatment
Other Outcomes (1)
Adverse Events During and After Treatment
Throughout treatment and follow-up period (baseline to 6 months)
Study Arms (3)
Sonic Activation
EXPERIMENTALSonic irrigation activation using Micron TA-200 with EDDY tips
Ultrasonic Activation (PUI)
EXPERIMENTALPassive ultrasonic irrigation using Ultra X activator
Conventional Needle Irrigation (Control)
ACTIVE COMPARATORManual syringe irrigation using a 30-gauge side-vented needle
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Aydın University Faculty of Dentistry
Istanbul, 34303, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 38878107BACKGROUNDArikan 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.
PMID: 39589537BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
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 INVESTIGATOR
- PI Title
- DDS
Study Record Dates
First Submitted
November 18, 2025
First Posted
November 25, 2025
Study Start
March 1, 2023
Primary Completion
February 12, 2025
Study Completion
March 12, 2025
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share