Effect of Irrigation Activation on Periapical HealingNCT06204887
Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions
A study testing Manual dynamic activation, Passive ultrasonic activation and Laser activation in people with Effect of Irrigation Activation on Periapical Healing, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Irrigation Activation on Periapical Healing
- What is being tested?
- Manual dynamic activation, Passive ultrasonic activation and Laser activation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 4 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having single root mandibular teeth
- Patients the diagnosis of chronic apical periodontitis,
- Periapical index score of 3 and above,
- Patients having good oral hygiene
Who cannot join
- Patients with systemic diseases (diabetes, hypertension, chronic liver disease, coagulation disorders),
- Patients with bone metabolism disease and/or
- Patients using drugs that affect bone metabolism (such as steroids, bisphosphonates)
- Patients with a history of radiotherapy
- Pregnant patients
- Teeth with mobility of 2 or more, periodontal pocket depth of 5 mm or more, generalized chronic periodontitis, internal and external resorption, and/or vertical and horizontal root fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Irrigation-Activation Techniques on Healing Outcome of Large Periapical Lesions: A Randomized Controlled Trial
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.
Read the detailed description
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.
A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values were statistically analyzed with the Wilcoxon test.
- Being tested
- Manual dynamic activation, Passive ultrasonic activation, Laser activation
- Keywords
- Irrigation activation, periapical healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual dynamic activationProcedure or surgery
The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
Passive ultrasonic activationProcedure or surgery
A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
Laser activationProcedure or surgery
A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
| Study group | Role | What they receive |
|---|---|---|
| Manual dynamic activation | Experimental | Not described Receives: Procedure: Manual dynamic activation |
| Passive ultrasonic activation | Experimental | Not described Receives: Procedure: Passive ultrasonic activation |
| Laser activation | Experimental | Not described Receives: Procedure: Laser activation |
| Non-activated Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Lesion Volume at 12-months Follow-up
3D volumes pre-operatively and at the end of 1 year were measured using the segmentation technique by slicing the image at 0.09 mm intervals. The borders of the lesion were determined with gray scale. The defined volume boundaries were automatically filled by bubbles until the entire defect was filled completely. If necessary, manual correction was applied at this stage of lesion volume measurements, allowing for small individual additions or subtractions. At the end, the well-defined size of the lesion could be visualized in 3D. After finishing the process, the software depicted the exact volume of the defects in mm3.The volume data were compared with the preoperative CBCT measurements in each case. The primary healing of the periapical tissues was assessed, volume changes were measured, and the long-term outcomes of the procedures were compared using percentage of the lesion volume change.
Measured: One year from the beginning of the study
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Measured: One year from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2021
- Primary completion27 Feb 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Irrigation Activation on Periapical HealingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahter Sanal Cikman, Recep Tayyip Erdogan University
- Investigators
- Ahter Şanal Çıkman, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204887
- Sponsor's protocol ID
- 2023/35
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2024
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 38878107
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Irrigation-Activation Techniques on Healing Outcome of Large Periapical Lesions: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06204887
- Acronym / sponsor ID
- 2023/35
- Keywords
- Irrigation activation, periapical healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.
Detailed description
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.
A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values were statistically analyzed with the Wilcoxon test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual dynamic activation | Experimental | Procedure: Manual dynamic activation |
| Passive ultrasonic activation | Experimental | Procedure: Passive ultrasonic activation |
| Laser activation | Experimental | Procedure: Laser activation |
| Non-activated Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having single root mandibular teeth
- Patients the diagnosis of chronic apical periodontitis,
- Periapical index score of 3 and above,
- Patients having good oral hygiene
Key exclusion criteria (6 listed)
- Patients with systemic diseases (diabetes, hypertension, chronic liver disease, coagulation disorders),
- Patients with bone metabolism disease and/or
- Patients using drugs that affect bone metabolism (such as steroids, bisphosphonates)
- Patients with a history of radiotherapy
- Pregnant patients
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 |
|---|---|---|
| Manual dynamic activationThe root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s. | Procedure or surgery | Manual dynamic activation |
| Passive ultrasonic activationA non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations. | Procedure or surgery | Passive ultrasonic activation |
| Laser activationA 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off. | Procedure or surgery | Laser activation |
Primary outcome
Percentage Change in Lesion Volume at 12-months Follow-up
Time frame: One year from the beginning of the study
3D volumes pre-operatively and at the end of 1 year were measured using the segmentation technique by slicing the image at 0.09 mm intervals. The borders of the lesion were determined with gray scale. The defined volume boundaries were automatically filled by bubbles until the entire defect was filled completely. If necessary, manual correction was applied at this stage of lesion volume measurements, allowing for small individual additions or subtractions. At the end, the well-defined size of the lesion could be visualized in 3D. After finishing the process, the software depicted the exact volume of the defects in mm3.The volume data were compared with the preoperative CBCT measurements in each case. The primary healing of the periapical tissues was assessed, volume changes were measured, and the long-term outcomes of the procedures were compared using percentage of the lesion volume change.
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Time frame: One year from the beginning of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
Related trials for Effect of Irrigation Activation on Periapical Healing
Active, not recruiting
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Effects of Irrigation Activation Systems on Postoperative Pain and Lesion Healing in Single-Visit Retreatment
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Recruiting
Evaluation of the Effect of Different Irrigation Activation Methods During Endodontic Retreatment
Endodontic Inflammation
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.
Ahter Şanal Çıkman principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual dynamic activation, Passive ultrasonic activation and Laser activation in people with Effect of Irrigation Activation on Periapical Healing, run by Recep Tayyip Erdogan University 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 4 inclusion and 6 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 24 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?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Lesion Volume at 12-months Follow-up (time frame: One year from the beginning of the study). The study lists 2 primary outcomes in all. 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 NCT06204887, which also lists 1 linked publication.
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 24 Dec 2025.