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

NCT07120126 | Completed

• 1 other identifier: 20/5
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  Baseline and immediately after instrumentation (same visit)

Secondary Outcomes (1)

• Postoperative Pain Level

  6, 12, 24, and 48 hours after treatment

Study Arms (2)

EDDY Group

EXPERIMENTAL

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

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.

Procedure: Conventional Syringe Irrigation

Interventions

Conventional Syringe Irrigation PROCEDURE

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

Conventional Irrigation Group

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.

EDDY Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abdulkadir Tiftik,DDS: lead

Study Sites (1)

Bezmialem Vakıf University, Faculty of Dentistry

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Diseases; Toothache; Periapical Periodontitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontitis; Postoperative Complications; Pathologic Processes

Study Officials

• Abdulkadir Tiftik, DDS, DDS

  Bezmialem Vakif University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Endodontics / Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: November 20, 2021
• Primary Completion: December 20, 2021
• Study Completion: January 10, 2022
• Last Updated: February 20, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)