Apical PeriodontitisSONIC-ULTRANCT07249450
Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis
A study testing Sonic Activation Irrigation, Passive Ultrasonic Irrigation (PUI) and Conventional Needle Irrigation in people with Apical Periodontitis, run by Hilal Çuhadar Beşiroğlu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Sonic Activation Irrigation, Passive Ultrasonic Irrigation (PUI) and Conventional Needle Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 12 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University Faculty of Dentistry
Istanbul, 34303
About this study
Official title: Comparison of Sonic and Ultrasonic Activation of Irrigation Solutions on the Healing of Teeth With 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.
Read more
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.
Read the 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.
- Conditions
- Apical Periodontitis
- Being tested
- Sonic Activation Irrigation, Passive Ultrasonic Irrigation (PUI), Conventional Needle Irrigation
- Keywords
- Apical Periodontitis, Periapical Healing, Sonic Activation, Passive Ultrasonic Activation
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonic Activation IrrigationProcedure or surgery
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 or surgery
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 IrrigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Sonic Activation | Experimental | Sonic irrigation activation using Micron TA-200 with EDDY tips Receives: Procedure: Sonic Activation Irrigation |
| Ultrasonic Activation (PUI) | Experimental | Passive ultrasonic irrigation using Ultra X activator Receives: Procedure: Passive Ultrasonic Irrigation (PUI) |
| Conventional Needle Irrigation (Control) | Active comparator | Manual syringe irrigation using a 30-gauge side-vented needle Receives: Procedure: Conventional Needle Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Change in Apical Lesion Volume Measured by Cone-Beam Computed Tomography (CBCT)
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.
Measured: Baseline to 6 months post-treatment
Secondary outcomes (2)
Percentage Reduction in Apical Lesion Volume
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.
Measured: Baseline to 6 months post-treatment
Radiographic Healing Status
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.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Mar 2023
- Primary completion12 Feb 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Çuhadar Beşiroğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Çuhadar Beşiroğlu, Istanbul Aydın University
- Investigators
- Işıl Kaya Büyükbayram, DDS, PhD, Study director, Istanbul Aydın University, Faculty of Dentistry, Department of EndodonticsHilal Cuhadar Besiroglu, DDS, Principal investigator, Istanbul Aydın University, Faculty of Dentistry Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249450
- Sponsor's protocol ID
- 2022/164
- Acronym
- SONIC-ULTRA
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dogan MU, Aricioglu B, Kose TE, Cikman AS, Oksuzer MC. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376. doi: 10.1007/s00784-024-05758-4.
PubMed 38878107Arikan NS, Hepsenoglu YE, Ersahan S, Ozcelik F. Periradicular repair after single-visit root canal treatment using sonic irrigant activation of teeth with apical periodontitis. Clin Oral Investig. 2024 Nov 26;28(12):656. doi: 10.1007/s00784-024-06059-6.
PubMed 39589537
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sonic and Ultrasonic Activation of Irrigation Solutions on the Healing of Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07249450
- Acronym / sponsor ID
- SONIC-ULTRA / 2022/164
- Conditions
- Apical Periodontitis
- Keywords
- Apical Periodontitis, Periapical Healing, Sonic Activation, Passive Ultrasonic Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hilal Çuhadar BeşiroğluUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Sonic Activation | Experimental | Procedure: Sonic Activation IrrigationSonic irrigation activation using Micron TA-200 with EDDY tips |
| Ultrasonic Activation (PUI) | Experimental | Procedure: Passive Ultrasonic Irrigation (PUI)Passive ultrasonic irrigation using Ultra X activator |
| Conventional Needle Irrigation (Control) | Active comparator | Procedure: Conventional Needle IrrigationManual syringe irrigation using a 30-gauge side-vented needle |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Pregnancy or lactation
- Individuals with mental retardation
- Allergy to Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), or latex
- Extensive structural loss that cannot be restored with a filling
- Presence of subgingival caries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonic Activation IrrigationRoot 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. | Procedure or surgery | Sonic Activation |
| 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. | Procedure or surgery | Ultrasonic Activation (PUI) |
| Conventional Needle IrrigationManual 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. | Procedure or surgery | Conventional Needle Irrigation (Control) |
Primary outcome
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.
2 secondary outcomes
Percentage Reduction in Apical Lesion Volume
Time frame: Baseline to 6 months post-treatment
Radiographic Healing Status
Time frame: 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 38878107Dogan MU, Aricioglu B, Kose TE, Cikman AS, Oksuzer MC. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376. doi: 10.1007/s00784-024-05758-4.
- Background: PubMed 39589537Arikan NS, Hepsenoglu YE, Ersahan S, Ozcelik F. Periradicular repair after single-visit root canal treatment using sonic irrigant activation of teeth with apical periodontitis. Clin Oral Investig. 2024 Nov 26;28(12):656. doi: 10.1007/s00784-024-06059-6.
- Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Işıl Kaya Büyükbayram, DDS, PhD study director
Istanbul Aydın University, Faculty of Dentistry, Department of Endodontics
Hilal Cuhadar Besiroglu, DDS principal investigator
Istanbul Aydın University, Faculty of Dentistry Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonic Activation Irrigation, Passive Ultrasonic Irrigation (PUI) and Conventional Needle Irrigation in people with Apical Periodontitis, run by Hilal Çuhadar Beşiroğlu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title: Change in Apical Lesion Volume Measured by Cone-Beam Computed Tomography (CBCT) (time frame: Baseline to 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249450, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.