Clinical Trials Directory

Trials / Completed

CompletedNCT07120126

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Abdulkadir Tiftik,DDS · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEEDDY Sonic ActivationSonic activation was performed using the EDDY device with 2.5% NaOCl and 17% EDTA solutions during final irrigation, following root canal preparation.
PROCEDUREConventional Syringe IrrigationFinal irrigation was performed using syringe irrigation with 2.5% NaOCl and 17% EDTA solutions, without any activation.

Timeline

Start date
2021-11-20
Primary completion
2021-12-20
Completion
2022-01-10
First posted
2025-08-13
Last updated
2026-02-20

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07120126. Inclusion in this directory is not an endorsement.