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

Not Applicable

Completed

• Conditions: Asymptomatic Apical Periodontitis; Root Canal Infection; Periapical Diseases; Dental Pain

• Registration Number: NCT07120126
• Lead Sponsor: Abdulkadir Tiftik,DDS

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.

Study Timeline

• Study Start: 2021-11-20
• Primary Completion: 2021-12-20
• Study Completion: 2022-01-10
• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Bacterial Load (CFU/mL) After Root Canal Treatment	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 Outcome Measures

Name	Time	Method
Postoperative Pain Level	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.; \[Time Frame: 6, 12, 24, and 48 hours after treatment\]

Trial Locations

Locations (1)

Bezmialem Vakıf University, Faculty of Dentistry; 🇹🇷 Istanbul, Turkey