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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-20

Study Completion Date

2022-01-10

Brief Summary

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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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Detailed Description

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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

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Asymptomatic Apical Periodontitis Root Canal Infection Periapical Diseases Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment of 40 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EDDY Group

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

Group Type EXPERIMENTAL

EDDY Sonic Activation

Intervention Type 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 Irrigation Group

Patients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation.

Group Type ACTIVE_COMPARATOR

Conventional Syringe Irrigation

Intervention Type PROCEDURE

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

Interventions

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EDDY 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.

Intervention Type DEVICE

Conventional Syringe Irrigation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No