Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT07249450
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis
Sponsor:
Hilal Çuhadar Beşiroğlu
Organization:
Study Overview
Official Title:
Comparison of Sonic and Ultrasonic Activation of Irrigation Solutions on the Healing of Teeth With Apical Periodontitis
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONIC-ULTRA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: