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NCT Number: NCT07120126

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

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.

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Key information

Conditions

Asymptomatic Apical Periodontitis Dental Pain Facial Pain Jaw Diseases Mouth Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Postoperative Complications Root Canal Infection Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University, Faculty of Dentistry

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (ASA I or II)
  • Ability to provide informed consent

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

Treatment and study plan

EDDY Sonic Activation

Device

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 Irrigation

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative Pain Level

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

    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]

Sponsors and collaborators

Lead sponsor

Abdulkadir Tiftik,DDS

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 13, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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