Chronic Apical PeriodontitisNCT07850895
Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis
A study testing Sonic Irrigation Activation, Passive Ultrasonic Irrigation and Laser-Activated Irrigation in people with Chronic Apical Periodontitis, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of different irrigation activation methods on periapical healing in teeth with chronic apical periodontitis. Patients underwent root canal treatment using one of three irrigation activation methods: sonic activation, passive ultrasonic irrigation, or laser-activated irrigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Apical Periodontitis
- What is being tested?
- Sonic Irrigation Activation, Passive Ultrasonic Irrigation and Laser-Activated Irrigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older
- Systemically healthy participants
- Mandibular premolar teeth diagnosed with pulp necrosis and chronic apical periodontitis
- Teeth undergoing single-visit root canal treatment
Who cannot join
- Use of any analgesic medication within 24 hours before root canal treatment or use of corticosteroid medications
- Use of antibiotics within 1 week before root canal treatment
- Pregnancy or breastfeeding
- Presence of any systemic disease, including conditions requiring antibiotic prophylaxis
- Presence of mental or psychiatric disorders
- Presence of swelling or pain on palpation before treatment
Show all 13Show fewer
- Presence of root resorption in the study tooth
- Presence of generalized periodontitis
- Presence of a periodontal pocket depth greater than 3 mm in the study tooth
- Teeth with root fracture, ankylosis, or pathological mobility
- Presence of a cystic lesion, defined as a lesion surrounded by a well-defined radiopaque border and causing displacement of adjacent teeth
- Teeth with radiographically very narrow or wide root canals
- Participants who did not attend the follow-up visit at least 6 months after root canal treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize, Rize Province
About this study
Official title: Evaluation of the Effects of Sonic, Ultrasonic, and Laser-Activated Irrigation on Periapical Healing in Teeth With Chronic Apical Periodontitis Using PAI and Fractal Analysis
This study aims to evaluate the effects of different irrigation activation methods on periapical healing in teeth with chronic apical periodontitis. Patients underwent root canal treatment using one of three irrigation activation methods: sonic activation, passive ultrasonic irrigation, or laser-activated irrigation. Periapical healing is evaluated by comparing baseline and follow-up periapical radiographs using the Periapical Index (PAI) and fractal analysis. PAI is used to assess changes in periapical status, while fractal dimension analysis is used to quantitatively evaluate changes in the trabecular bone structure in the periapical region. The study aims to determine whether the irrigation activation method used during root canal treatment influences subsequent periapical healing.
- Conditions
- Chronic Apical Periodontitis
- Being tested
- Sonic Irrigation Activation, Passive Ultrasonic Irrigation, Laser-Activated Irrigation
- Keywords
- Periapical Healing, Irrigation Activation, Sonic Activation, Passive Ultrasonic Irrigation, Laser-Activated Irrigation, Periapical Index, Fractal Analysis, Root Canal Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonic Irrigation ActivationDevice
Irrigating solutions were activated using a sonic activation device. The activation tip was positioned 2 mm short of the working length, and sonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds.
Passive Ultrasonic IrrigationDevice
Irrigating solutions were activated using a passive ultrasonic irrigation device in endodontic mode. The activation tip was positioned 2 mm short of the working length, and ultrasonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds.
Laser-Activated IrrigationDevice
Irrigating solutions were activated using an Er:YAG laser with the following parameters: SSP mode (50 μs), 0.3 W, 15 Hz, and 20 mJ. A radial laser tip was positioned in the coronal pulp chamber, and activation was performed for three 20-second cycles, for a total activation time of 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Sonic Activation | Experimental | Root canal treatment was performed using sonic activation for irrigation. The irrigating solutions were activated using a sonic activation device, with the activation tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles. Receives: Device: Sonic Irrigation Activation |
| Passive Ultrasonic Irrigation | Experimental | Root canal treatment was performed using passive ultrasonic irrigation. The irrigating solutions were ultrasonically activated with the tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles. Receives: Device: Passive Ultrasonic Irrigation |
| Laser-Activated Irrigation | Experimental | Root canal treatment was performed using Er:YAG laser-activated irrigation. Laser activation was performed from the coronal pulp chamber for three 20-second cycles. Receives: Device: Laser-Activated Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periapical Index (PAI)
Periapical healing will be assessed using the Periapical Index (PAI) on periapical radiographs. PAI scores range from 1 to 5, with lower scores indicating healthier periapical conditions and higher scores indicating greater severity of periapical pathology. Changes in PAI scores between baseline and follow-up radiographs will be evaluated.
Measured: Baseline and at least 6 months after root canal treatment
Change in Fractal Dimension (FD)
Fractal dimension (FD) will be calculated from standardized regions of interest on periapical radiographs using ImageJ software and the box-counting method. Changes in FD values between baseline and follow-up radiographs will be evaluated to quantitatively assess changes in the trabecular bone structure in the periapical region.
Measured: Baseline and at least 6 months after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start6 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burcu revi, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850895
- Sponsor's protocol ID
- 2026/183
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Sonic, Ultrasonic, and Laser-Activated Irrigation on Periapical Healing in Teeth With Chronic Apical Periodontitis Using PAI and Fractal Analysis
- ClinicalTrials.gov ID
- NCT07850895
- Acronym / sponsor ID
- 2026/183
- Conditions
- Chronic Apical Periodontitis
- Keywords
- Periapical Healing, Irrigation Activation, Sonic Activation, Passive Ultrasonic Irrigation, Laser-Activated Irrigation, Periapical Index, Fractal Analysis, Root Canal Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Sep 2026 (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.
This study aims to evaluate the effects of different irrigation activation methods on periapical healing in teeth with chronic apical periodontitis. Patients underwent root canal treatment using one of three irrigation activation methods: sonic activation, passive ultrasonic irrigation, or laser-activated irrigation. Periapical healing is evaluated by comparing baseline and follow-up periapical radiographs using the Periapical Index (PAI) and fractal analysis. PAI is used to assess changes in periapical status, while fractal dimension analysis is used to quantitatively evaluate changes in the trabecular bone structure in the periapical region. The study aims to determine whether the irrigation activation method used during root canal treatment influences subsequent periapical healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sonic Activation | Experimental | Device: Sonic Irrigation ActivationRoot canal treatment was performed using sonic activation for irrigation. The irrigating solutions were activated using a sonic activation device, with the activation tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles. |
| Passive Ultrasonic Irrigation | Experimental | Device: Passive Ultrasonic IrrigationRoot canal treatment was performed using passive ultrasonic irrigation. The irrigating solutions were ultrasonically activated with the tip positioned 2 mm short of the working length. Activation was performed for three 20-second cycles. |
| Laser-Activated Irrigation | Experimental | Device: Laser-Activated IrrigationRoot canal treatment was performed using Er:YAG laser-activated irrigation. Laser activation was performed from the coronal pulp chamber for three 20-second cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 years or older
- Systemically healthy participants
- Mandibular premolar teeth diagnosed with pulp necrosis and chronic apical periodontitis
- Teeth undergoing single-visit root canal treatment
Key exclusion criteria (13 listed)
- Use of any analgesic medication within 24 hours before root canal treatment or use of corticosteroid medications
- Use of antibiotics within 1 week before root canal treatment
- Pregnancy or breastfeeding
- Presence of any systemic disease, including conditions requiring antibiotic prophylaxis
- Presence of mental or psychiatric disorders
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 Irrigation ActivationIrrigating solutions were activated using a sonic activation device. The activation tip was positioned 2 mm short of the working length, and sonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds. | Device | Sonic Activation |
| Passive Ultrasonic IrrigationIrrigating solutions were activated using a passive ultrasonic irrigation device in endodontic mode. The activation tip was positioned 2 mm short of the working length, and ultrasonic activation was performed for three 20-second cycles, for a total activation time of 60 seconds. | Device | Passive Ultrasonic Irrigation |
| Laser-Activated IrrigationIrrigating solutions were activated using an Er:YAG laser with the following parameters: SSP mode (50 μs), 0.3 W, 15 Hz, and 20 mJ. A radial laser tip was positioned in the coronal pulp chamber, and activation was performed for three 20-second cycles, for a total activation time of 60 seconds. | Device | Laser-Activated Irrigation |
Primary outcome
Change in Periapical Index (PAI)
Time frame: Baseline and at least 6 months after root canal treatment
Periapical healing will be assessed using the Periapical Index (PAI) on periapical radiographs. PAI scores range from 1 to 5, with lower scores indicating healthier periapical conditions and higher scores indicating greater severity of periapical pathology. Changes in PAI scores between baseline and follow-up radiographs will be evaluated.
Change in Fractal Dimension (FD)
Time frame: Baseline and at least 6 months after root canal treatment
Fractal dimension (FD) will be calculated from standardized regions of interest on periapical radiographs using ImageJ software and the box-counting method. Changes in FD values between baseline and follow-up radiographs will be evaluated to quantitatively assess changes in the trabecular bone structure in the periapical region.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
Active, not recruiting
Rotary Versus Manual Degranulation in Alveolar Ridge Preservation
Chronic Periapical Periodontitis, Alveolar Ridge Preservation
Not yet recruiting
Regenerative Endodontics in Mature Necrotic Teeth
Necrotic Teeth With Chronic Apical Periodontitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irrigation Activation, Passive Ultrasonic Irrigation and Laser-Activated Irrigation in people with Chronic Apical Periodontitis, 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 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Periapical Index (PAI) (time frame: Baseline and at least 6 months after root canal treatment). 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?
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 30 Sep 2026.