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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07120126
Enrollment
40
Registered
2025-08-13
Start date
2021-11-20
Completion date
2022-01-10
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

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.

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

Sponsors

Abdulkadir Tiftik,DDS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Bacterial Load (CFU/mL) After Root Canal TreatmentBaseline 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

MeasureTime frameDescription
Postoperative Pain Level6, 12, 24, and 48 hours after treatmentPostoperative 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. \[Time Frame: 6, 12, 24, and 48 hours after treatment\]

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAbdulkadir Tiftik, DDS, DDS

Bezmialem Vakif University, Faculty of Dentistry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026