Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sonic vs Passive Ultrasonic Irrigation for Chronic Apical Periodontitis

NCT07069881

Chronic Apical Periodontitis

RECRUITING NA

Efficacy of Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria

NCT07005219

Periapical Periodontitis Root Canal Infection

COMPLETED NA

Evaluation of Different Root Canal Irrigation Techniques

NCT07106320

Apical Periodontitis

COMPLETED NA

Microbial Load After Apical Enlargement in Asymptomatic Teeth With Periapical Lesion

NCT06035185

Root Canal Infection Periapical Diseases Periapical; Infection +1 more

NOT_YET_RECRUITING

Effect of Passive Ultrasonic Irrigation Versus Needle Irrigation on Postoperative Pain and Periapical Healing

NCT02913937

Apical Periodontitis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Apical Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sonic Activation

Sonic irrigation activation using Micron TA-200 with EDDY tips

Group Type EXPERIMENTAL

Sonic Activation Irrigation

Intervention Type 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.

Ultrasonic Activation (PUI)

Passive ultrasonic irrigation using Ultra X activator

Group Type EXPERIMENTAL

Passive Ultrasonic Irrigation (PUI)

Intervention Type 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 (Control)

Manual syringe irrigation using a 30-gauge side-vented needle

Group Type ACTIVE_COMPARATOR

Conventional Needle Irrigation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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

Minimum Eligible Age

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes