Asymptomatic Apical PeriodontitisNCT07120126
Effect of EDDY Sonic Irrigation on Root Canal Microbiota and Pain in Asymptomatic Apical Periodontitis
A study testing EDDY Sonic Activation and Conventional Syringe Irrigation in people with Asymptomatic Apical Periodontitis and Root Canal Infection, run by Abdulkadir Tiftik,DDS at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled clinical trial aimed to evaluate the effect of sonic activation using the EDDY device on root canal microbiota and postoperative pain in teeth with asymptomatic apical periodontitis. Forty patients were assigned to either a sonic activation group (EDDY) or a conventional irrigation group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Apical Periodontitis, Root Canal Infection, Periapical Diseases
- What is being tested?
- EDDY Sonic Activation and Conventional Syringe 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2021to 10 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Presence of a single-rooted tooth diagnosed with asymptomatic apical periodontitis
- No previous endodontic treatment on the involved tooth
- Good general health (ASA I or II)
- Ability to provide informed consent
Who cannot join
- Teeth with internal or external resorption
- Pregnant or breastfeeding women
- Systemic antibiotic or anti-inflammatory drug use within the past 30 days
- Patients with periodontal pockets >4 mm on the affected tooth
- Known allergy to sodium hypochlorite or EDTA
- Patients who failed to attend postoperative pain follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University, Faculty of Dentistry
Istanbul, 34093
About this study
Official title: Evaluation of the Effect of Sonic Activation Using the EDDY Device on Root Canal Microbiota and Postoperative Pain in Teeth With Asymptomatic Apical Periodontitis: A Prospective Randomized Controlled Clinical Trial
This randomized controlled clinical trial aimed to evaluate the effect of sonic activation using the EDDY device on root canal microbiota and postoperative pain in teeth with asymptomatic apical periodontitis. Forty patients were assigned to either a sonic activation group (EDDY) or a conventional irrigation group. Bacterial samples were collected before and after root canal treatment and analyzed using real-time PCR. Postoperative pain was assessed using a Numerical Rating Scale at various time intervals. The results showed that EDDY sonic activation significantly reduced bacterial load, while no statistically significant difference was found in postoperative pain between the groups.
Read the detailed description
This prospective, randomized controlled clinical trial was conducted to assess the impact of sonic irrigation using the EDDY device on the reduction of intracanal microbiota and on postoperative pain following root canal treatment of teeth with asymptomatic apical periodontitis. Forty participants with single-rooted teeth were randomly allocated into two groups: the EDDY group, which received final irrigation activated with the EDDY sonic system, and the control group, which received conventional syringe irrigation. Microbiological samples were collected before and after instrumentation and were analyzed using real-time PCR to detect specific bacterial taxa. Postoperative pain levels were recorded using the Numerical Rating Scale at multiple time intervals up to 48 hours after treatment. The results demonstrated a statistically significant reduction in bacterial load in the EDDY group compared to the control group, but no significant difference in postoperative pain was observed. The findings support the use of EDDY sonic activation as an effective method for enhancing root canal disinfection.
- Being tested
- EDDY Sonic Activation, Conventional Syringe Irrigation
- Keywords
- EDDY Device, Sonic Irrigation, Root Canal Treatment, Apical Periodontitis, Postoperative Pain, Real-Time PCR, Randomized Controlled Trial
- Medical subject headings
- Periapical Diseases, Toothache, Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDDY Sonic ActivationDevice
Sonic activation was performed using the EDDY device with 2.5% NaOCl and 17% EDTA solutions during final irrigation, following root canal preparation.
Conventional Syringe IrrigationProcedure or surgery
Final irrigation was performed using syringe irrigation with 2.5% NaOCl and 17% EDTA solutions, without any activation.
| Study group | Role | What they receive |
|---|---|---|
| EDDY Group | Experimental | Patients in this group received final irrigation using the EDDY sonic activation device after standard root canal instrumentation. Receives: Device: EDDY Sonic Activation |
| Conventional Irrigation Group | Active comparator | Patients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation. Receives: Procedure: Conventional Syringe Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacterial Load (CFU/mL) After Root Canal Treatment
Bacterial samples were taken from the root canal before and after treatment. Quantitative changes in bacterial load were assessed using real-time PCR analysis of selected bacterial taxa.
Measured: Baseline and immediately after instrumentation (same visit)
Secondary outcomes (1)
Postoperative Pain Level
Postoperative Pain Level Patients were asked to rate their pain using the Numerical Rating Scale (range 0-10; 0 = no pain, 10 = worst possible pain) at 4 time points after treatment. Higher scores indicate greater pain intensity. Pain scores were compared between groups.
[Time Frame: 6, 12, 24, and 48 hours after treatment]
Measured: 6, 12, 24, and 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start20 Nov 2021
- Primary completion20 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic 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
- Parallel assignment of 54 participants into two groups: one receiving sonic irrigation using the EDDY device and the other receiving conventional syringe irrigation. Each participant received a single intervention without crossover.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdulkadir Tiftik,DDS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdulkadir Tiftik,DDS, Bezmialem Vakif University
- Investigators
- Abdulkadir Tiftik, DDS, DDS, Principal investigator, Bezmialem Vakif University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120126
- Sponsor's protocol ID
- 20/5
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because the study was conducted locally with a limited sample size, and there is no institutional plan or repository in place for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Sonic Activation Using the EDDY Device on Root Canal Microbiota and Postoperative Pain in Teeth With Asymptomatic Apical Periodontitis: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07120126
- Acronym / sponsor ID
- 20/5
- Keywords
- EDDY Device, Sonic Irrigation, Root Canal Treatment, Apical Periodontitis, Postoperative Pain, Real-Time PCR, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abdulkadir Tiftik,DDSUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 13 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 randomized controlled clinical trial aimed to evaluate the effect of sonic activation using the EDDY device on root canal microbiota and postoperative pain in teeth with asymptomatic apical periodontitis. Forty patients were assigned to either a sonic activation group (EDDY) or a conventional irrigation group. Bacterial samples were collected before and after root canal treatment and analyzed using real-time PCR. Postoperative pain was assessed using a Numerical Rating Scale at various time intervals. The results showed that EDDY sonic activation significantly reduced bacterial load, while no statistically significant difference was found in postoperative pain between the groups.
Detailed description
This prospective, randomized controlled clinical trial was conducted to assess the impact of sonic irrigation using the EDDY device on the reduction of intracanal microbiota and on postoperative pain following root canal treatment of teeth with asymptomatic apical periodontitis. Forty participants with single-rooted teeth were randomly allocated into two groups: the EDDY group, which received final irrigation activated with the EDDY sonic system, and the control group, which received conventional syringe irrigation. Microbiological samples were collected before and after instrumentation and were analyzed using real-time PCR to detect specific bacterial taxa. Postoperative pain levels were recorded using the Numerical Rating Scale at multiple time intervals up to 48 hours after treatment. The results demonstrated a statistically significant reduction in bacterial load in the EDDY group compared to the control group, but no significant difference in postoperative pain was observed. The findings support the use of EDDY sonic activation as an effective method for enhancing root canal disinfection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment of 54 participants into two groups: one receiving sonic irrigation using the EDDY device and the other receiving conventional syringe irrigation. Each participant received a single intervention without crossover.
| Arm | Type | Receives |
|---|---|---|
| EDDY Group | Experimental | Device: EDDY Sonic ActivationPatients in this group received final irrigation using the EDDY sonic activation device after standard root canal instrumentation. |
| Conventional Irrigation Group | Active comparator | Procedure: Conventional Syringe IrrigationPatients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- Presence of a single-rooted tooth diagnosed with asymptomatic apical periodontitis
- No previous endodontic treatment on the involved tooth
- Good general health (ASA I or II)
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Teeth with internal or external resorption
- Pregnant or breastfeeding women
- Systemic antibiotic or anti-inflammatory drug use within the past 30 days
- Patients with periodontal pockets >4 mm on the affected tooth
- Known allergy to sodium hypochlorite or EDTA
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 |
|---|---|---|
| EDDY Sonic ActivationSonic activation was performed using the EDDY device with 2.5% NaOCl and 17% EDTA solutions during final irrigation, following root canal preparation. | Device | EDDY Group |
| Conventional Syringe IrrigationFinal irrigation was performed using syringe irrigation with 2.5% NaOCl and 17% EDTA solutions, without any activation. | Procedure or surgery | Conventional Irrigation Group |
Primary outcome
Change in Bacterial Load (CFU/mL) After Root Canal Treatment
Time frame: Baseline and immediately after instrumentation (same visit)
Bacterial samples were taken from the root canal before and after treatment. Quantitative changes in bacterial load were assessed using real-time PCR analysis of selected bacterial taxa.
1 secondary outcome
Postoperative Pain Level
Time frame: 6, 12, 24, and 48 hours after 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 20 Feb 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because the study was conducted locally with a limited sample size, and there is no institutional plan or repository in place for data sharing.
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Effects of Intracanal Cryotherapy on Biomarkers and Postoperative Pain in Apical Periodontitis
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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.
Abdulkadir Tiftik, DDS, DDS principal investigator
Bezmialem Vakif University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDDY Sonic Activation and Conventional Syringe Irrigation in people with Asymptomatic Apical Periodontitis and Root Canal Infection, run by Abdulkadir Tiftik,DDS 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 5 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 20 Feb 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?
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?
Change in Bacterial Load (CFU/mL) After Root Canal Treatment (time frame: Baseline and immediately after instrumentation (same visit)). 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 20 Feb 2026.