Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis (NCT07249450) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis
Turkey (Türkiye)42 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
13 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Title: Change in Apical Lesion Volume Measured by Cone-Beam Computed Tomography (CBCT)