Istanbul Aydın University Faculty of Dentistry
Istanbul, 34303, Turkey (Türkiye)
NCT Number: NCT07249450
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.
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Notify Me13 year–65 year
All sexes
Interventional
Not applicable
Istanbul, 34303, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• American Society of Anesthesiologists physical status classification system (ASA) class I and II
Tooth-related:
Exclusion criteria
• ASA class III or higher
Tooth-related:
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.
Time frame: Baseline to 6 months post-treatment
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.
Time frame: Baseline to 6 months post-treatment
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.
Time frame: 6 months post-treatment
Qualitative classification of periapical healing on CBCT and digital periapical radiographs into:
Time frame: Throughout treatment and follow-up period (baseline to 6 months)
Number and type of clinical complications during or after endodontic treatment (flare-ups, swelling, restoration loss, or tooth fracture).
Hilal Çuhadar Beşiroğlu
Other
Comparison of Sonic and Ultrasonic Activation of Irrigation Solutions on the Healing of Teeth With Apical Periodontitis
Acronym: SONIC-ULTRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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