ClinicalTrials.gg
CompletedNCT07120126Updated Feb 20, 2026

Effect of EDDY Sonic Irrigation on Root Canal Microbiota and Pain in Asymptomatic Apical Periodontitis

An interventional study of EDDY Sonic Activation and Conventional Syringe Irrigation in Asymptomatic Apical Periodontitis, Root Canal Infection and Periapical Diseases, sponsored by Abdulkadir Tiftik,DDS. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-20.

Primary conditionPeriapical PeriodontitisRegistry: Periapical DiseasesReclassifiedWhy we changed it
Registry
Periapical Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Periapical Periodontitis
Why
  1. The study's listed conditions name Periapical Periodontitis, a narrower term within Periapical Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Abdulkadir Tiftik,DDS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Nov 2021, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asymptomatic Apical Periodontitis
  • Root Canal Infection
  • Periapical Diseases
  • Dental Pain

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Keywords

  • EDDY Device
  • Sonic Irrigation
  • Root Canal Treatment
  • Apical Periodontitis
  • Postoperative Pain
  • Real-Time PCR
  • Randomized Controlled Trial
03

In context

Periapical Periodontitis Reclassified

280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.

Browse Periapical Periodontitis studies →

Lead sponsor

This is the only study on the registry with Abdulkadir Tiftik,DDS as lead sponsor.

Compared within Periapical Periodontitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Periapical Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ()
  • Ability to provide

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    EDDY Group

    Patients in this group received final irrigation using the EDDY sonic activation device after standard root canal instrumentation.

    Device: EDDY Sonic Activation

  • Active comparator
    Conventional Irrigation Group

    Patients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation.

    Procedure: Conventional Syringe Irrigation

Interventions

  • DeviceEDDY Sonic Activation

    Sonic activation was performed using the EDDY device with 2.5% NaOCl and 17% EDTA solutions during final irrigation, following root canal preparation.

  • ProcedureConventional Syringe Irrigation

    Final irrigation was performed using syringe irrigation with 2.5% NaOCl and 17% EDTA solutions, without any activation.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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. \[Time Frame: 6, 12, 24, and 48 hours after treatment\]

    Time frame: 6, 12, 24, and 48 hours after treatment

07

Study locations

1 site
  • Bezmialem Vakıf University, Faculty of Dentistry
    Istanbul, 34093, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07120126
Lead sponsor
Abdulkadir Tiftik,DDS
Responsible party
Abdulkadir Tiftik,DDS (Specialist in Endodontics / Researcher, Bezmialem Vakif University) — Sponsor-investigator
First posted
Aug 13, 2025
Start date
Nov 20, 2021
Primary completion
Dec 20, 2021
Completion
Jan 10, 2022
Last update
Feb 20, 2026

Study contacts

Abdulkadir Tiftik, DDS, DDS
principal investigator · Bezmialem Vakif University, Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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