Skip to main content
OpenTrials
Completed

NCT Number: NCT07249450

Comparison of Sonic and Ultrasonic Activation on Healing of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University Faculty of Dentistry

Istanbul, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Sonic Activation Irrigation

Procedure

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.

Passive Ultrasonic Irrigation (PUI)

Procedure

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.

Conventional Needle Irrigation

Procedure

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.

Primary outcomes

  1. Title: Change in Apical Lesion Volume Measured by Cone-Beam Computed Tomography (CBCT)

    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.

Secondary outcomes

  1. Percentage Reduction in Apical Lesion Volume

    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.

  2. Radiographic Healing Status

    Time frame: 6 months post-treatment

    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.

Other outcomes

  1. Adverse Events During and After Treatment

    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).

Sponsors and collaborators

Lead sponsor

Hilal Çuhadar Beşiroğlu

Other

Registry information

Official study title

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

Acronym: SONIC-ULTRA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.