Apical PeriodontitisNCT07106320
Evaluation of Different Root Canal Irrigation Techniques
A study testing VDW Ultra Ultrasonic Irrigation Activation, EDDY Sonic Irrigation Activation and Conventional Needle Irrigation in people with Apical Periodontitis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- VDW Ultra Ultrasonic Irrigation Activation, EDDY Sonic Irrigation Activation and Conventional Needle Irrigation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 1 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years
- Premolar and molar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
- Systemically healthy individuals
- To be able to read and sign the informed consent form
- Physical and mental fitness to undergo treatment
- Willingness to attend all follow-up sessions
Who cannot join
- Patients with systemic diseases classified as ASA III or higher
- Presence of severe periodontal disease (probing depth >4 mm)
- Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Faculty of Dentistry
Istanbul, Esenler
About this study
Official title: Evaluation of the Effect of Different Root Canal Irrigation Techniques on Periapical Tissue Healing and Postoperative Pain in Teeth With Apical Periodontitis
This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). A total of 162 patients are randomly assigned to one of three groups: (1) sonic irrigation activation using EDDY, (2) ultrasonic irrigation activation using VDW Ultra, and (3) conventional syringe irrigation as the control. Postoperative pain will be recorded using the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) at multiple time points up to one month. Periapical healing will be assessed using periapical imaging performed with the parallel technique one year after treatment. The study aims to determine whether enhanced irrigation techniques provide superior clinical outcomes compared to traditional methods.
Read the detailed description
Root canal treatment aims to eliminate microorganisms and their byproducts from the complex root canal system to allow periapical tissue healing. Due to the anatomical complexity of root canals-such as isthmuses, apical deltas, and lateral canals-mechanical preparation alone is often insufficient. Therefore, chemical irrigation plays a vital role in successful disinfection.
This randomized clinical trial investigates the influence of three different irrigation protocols on postoperative pain and periapical healing in permanent premolar and molar teeth with radiographically evident apical periodontitis (Periapical Index (PAI) score 4-5).
The study includes three experimental groups :
Group 1 (Sonic activation): Irrigation solution is activated using the EDDY sonic tip.
Group 2 (Ultrasonic activation): Irrigation is activated using VDW Ultra ultrasonic tips.
Group 3 (Control): Conventional needle irrigation is performed without activation.
All treatments will be performed under rubber dam isolation and local anesthesia, using a standardized instrumentation protocol with ProTaper Next rotary files. Between each file change, the root canal will be irrigated with 5 ml of 3% sodium hypochlorite (NaOCl). The final irrigation protocol will be applied according to the assigned group. All endodontic procedures will be completed in a single session.
Postoperative pain levels will be assessed using both the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) scales at 6, 12, 18, 24, 48, and 72 hours, as well as on day 7 and at 1 month. Patients will be asked to record analgesic consumption (400 mg ibuprofen as needed) and will submit pain diaries.
One year after treatment, periapical healing will be evaluated using periapical radiography (parallel technique) by two blinded observers.
.
- Conditions
- Apical Periodontitis
- Being tested
- VDW Ultra Ultrasonic Irrigation Activation, EDDY Sonic Irrigation Activation, Conventional Needle Irrigation
- Keywords
- Irrigation activation, Sonic activation, Ultrasonic activation, Apical periodontitis, Periapical Healing, Post operative pain
- Medical subject headings
- Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDW Ultra Ultrasonic Irrigation ActivationDevice
Irrigation will be activated using an ultrasonic tip (IRRI S 21/25) connected to the VDW Ultra device (VDW GmbH, Munich, Germany), 2 mm short of working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.
EDDY Sonic Irrigation ActivationDevice
Irrigation solution will be activated using the EDDY sonic tip (VDW GmbH, Munich, Germany), positioned 2 mm short of the working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times.
Conventional Needle IrrigationProcedure or surgery
Irrigation will be performed using a syringe and needle without activation. A total of 6 ml NaOCl, 2 ml EDTA and 5 mL of sterile saline will be used during final irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Irrigation Activation (VDW Ultra) | Experimental | Irrigation will be activated using an ultrasonic device (VDW Ultra) with an IRRI S tip positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated ultrasonically for 20seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions. Receives: Device: VDW Ultra Ultrasonic Irrigation Activation |
| Sonic Irrigation Activation (EDDY) | Experimental | Irrigation will be activated using a sonic device (EDDY tip, VDW) positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated for 20 seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions. Receives: Device: EDDY Sonic Irrigation Activation |
| Conventional Irrigation (Control) | Active comparator | Irrigation will be performed using a syringe and needle without activation. Final irrigation will be performed using conventional syringe and needle irrigation without any activation. Each canal will be irrigated with 6 mL of 3% Sodium Hypochlorite (NaOCl), followed by 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) and 5 mL of sterile saline, using a 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.
Periapical Healing
The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).
Measured: From end of treatment to 1 year
Secondary outcomes (1)
Postoperative Pain Intensity - Visual Analog Scale
The secondary outcome is postoperative pain intensity. Pain will be assessed at multiple time points (6, 12, 18, 24, 48, and 72 hours, and at 1 week and 1 month post-treatment) using Visual Analog Scale (VAS) where 0 represents "no pain" and 10 represents "worst imaginable pain".
Measured: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month 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 posted6 Aug 2025
- Study start15 Nov 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASLI USTA TAHMAZ, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106320
- Sponsor's protocol ID
- E-10840098-772.02-6497
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Root Canal Irrigation Techniques on Periapical Tissue Healing and Postoperative Pain in Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07106320
- Acronym / sponsor ID
- E-10840098-772.02-6497
- Conditions
- Apical Periodontitis
- Keywords
- Irrigation activation, Sonic activation, Ultrasonic activation, Apical periodontitis, Periapical Healing, Post operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Aug 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.
This clinical study aims to evaluate the effect of different root canal irrigation techniques on postoperative pain levels and periapical healing in premolar and molar teeth diagnosed with apical periodontitis (Periapical Index (PAI) score 4-5). A total of 162 patients are randomly assigned to one of three groups: (1) sonic irrigation activation using EDDY, (2) ultrasonic irrigation activation using VDW Ultra, and (3) conventional syringe irrigation as the control. Postoperative pain will be recorded using the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) at multiple time points up to one month. Periapical healing will be assessed using periapical imaging performed with the parallel technique one year after treatment. The study aims to determine whether enhanced irrigation techniques provide superior clinical outcomes compared to traditional methods.
Detailed description
Root canal treatment aims to eliminate microorganisms and their byproducts from the complex root canal system to allow periapical tissue healing. Due to the anatomical complexity of root canals-such as isthmuses, apical deltas, and lateral canals-mechanical preparation alone is often insufficient. Therefore, chemical irrigation plays a vital role in successful disinfection.
This randomized clinical trial investigates the influence of three different irrigation protocols on postoperative pain and periapical healing in permanent premolar and molar teeth with radiographically evident apical periodontitis (Periapical Index (PAI) score 4-5).
The study includes three experimental groups :
Group 1 (Sonic activation): Irrigation solution is activated using the EDDY sonic tip.
Group 2 (Ultrasonic activation): Irrigation is activated using VDW Ultra ultrasonic tips.
Group 3 (Control): Conventional needle irrigation is performed without activation.
All treatments will be performed under rubber dam isolation and local anesthesia, using a standardized instrumentation protocol with ProTaper Next rotary files. Between each file change, the root canal will be irrigated with 5 ml of 3% sodium hypochlorite (NaOCl). The final irrigation protocol will be applied according to the assigned group. All endodontic procedures will be completed in a single session.
Postoperative pain levels will be assessed using both the Visual Analog Scale (VAS) and Visual Analog Scale (VRS) scales at 6, 12, 18, 24, 48, and 72 hours, as well as on day 7 and at 1 month. Patients will be asked to record analgesic consumption (400 mg ibuprofen as needed) and will submit pain diaries.
One year after treatment, periapical healing will be evaluated using periapical radiography (parallel technique) by two blinded observers.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Irrigation Activation (VDW Ultra) | Experimental | Device: VDW Ultra Ultrasonic Irrigation ActivationIrrigation will be activated using an ultrasonic device (VDW Ultra) with an IRRI S tip positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated ultrasonically for 20seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions. |
| Sonic Irrigation Activation (EDDY) | Experimental | Device: EDDY Sonic Irrigation ActivationIrrigation will be activated using a sonic device (EDDY tip, VDW) positioned 2 mm short of the working length. Final irrigation protocol: Each canal receives a total of 6 mL of 3% Sodium Hypochlorite (NaOCl), will be delivered in three separate 2 mL portions. Each portion will be activated for 20 seconds. Subsequently, 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) will be introduced into per canal and similarly activated for 20 seconds to facilitate smear layer removal. As a final rinse, 5 mL of sterile saline will be used to flush out any residual irrigants and prevent potential chemical interactions. |
| Conventional Irrigation (Control) | Active comparator | Procedure: Conventional Needle IrrigationIrrigation will be performed using a syringe and needle without activation. Final irrigation will be performed using conventional syringe and needle irrigation without any activation. Each canal will be irrigated with 6 mL of 3% Sodium Hypochlorite (NaOCl), followed by 2 mL of 17% Ethylenediaminetetraacetic Acid (EDTA) and 5 mL of sterile saline, using a side-vented needle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 60 years
- Premolar and molar teeth with radiographically confirmed periapical lesions classified as Periapical Index (PAI) scores of 4 or 5 will be included in the analysis
- Systemically healthy individuals
- To be able to read and sign the informed consent form
- Physical and mental fitness to undergo treatment
Key exclusion criteria (3 listed)
- Patients with systemic diseases classified as ASA III or higher
- Presence of severe periodontal disease (probing depth >4 mm)
- Use of analgesics within the last 12 hours or antibiotics within the past month before the treatment
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 |
|---|---|---|
| VDW Ultra Ultrasonic Irrigation ActivationIrrigation will be activated using an ultrasonic tip (IRRI S 21/25) connected to the VDW Ultra device (VDW GmbH, Munich, Germany), 2 mm short of working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times. | Device | Ultrasonic Irrigation Activation (VDW Ultra) |
| EDDY Sonic Irrigation ActivationIrrigation solution will be activated using the EDDY sonic tip (VDW GmbH, Munich, Germany), positioned 2 mm short of the working length. NaOCl and EDTA will each be activated for 20 seconds, repeated three times. | Device | Sonic Irrigation Activation (EDDY) |
| Conventional Needle IrrigationIrrigation will be performed using a syringe and needle without activation. A total of 6 ml NaOCl, 2 ml EDTA and 5 mL of sterile saline will be used during final irrigation. | Procedure or surgery | Conventional Irrigation (Control) |
Primary outcome
Periapical Healing
Time frame: From end of treatment to 1 year
The primary outcome of this study is periapical healing. It will be assessed radiographically using standardized periapical images (taken with the parallel technique), captured preoperatively and at the 1-year follow-up, and evaluated using the Periapical Index (PAI) score by two blinded observers. The PAI score ranges from 1 (healthy periapical structures) to 5 (severe periodontitis).
1 secondary outcome
Postoperative Pain Intensity - Visual Analog Scale
Time frame: From end of treatment to 6, 12, 18, 24, 48, and 72 hours; 7 days; and 1 month after root canal 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 6 Aug 2025.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD), including all IPD that underlie the results reported in the publication
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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.
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 VDW Ultra Ultrasonic Irrigation Activation, EDDY Sonic Irrigation Activation and Conventional Needle Irrigation in people with Apical Periodontitis, run by Medipol 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 6 inclusion and 3 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 6 Aug 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?
Periapical Healing (time frame: From end of treatment to 1 year). 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 6 Aug 2025.