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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDDY Group | Experimental | Patients in this group received final irrigation using the EDDY sonic activation device after standard root canal instrumentation. |
|
| Conventional Irrigation Group | Active Comparator | Patients in this group received final irrigation with conventional syringe irrigation after standard root canal instrumentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Level | 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] | 6, 12, 24, and 48 hours after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdulkadir Tiftik, DDS, DDS | Bezmialem Vakif University, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakıf University, Faculty of Dentistry | Istanbul | 34093 | Turkey (Türkiye) |
The individual participant data (IPD) will not be shared because the study was conducted locally with a limited sample size, and there is no institutional plan or repository in place for data sharing.
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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.
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| Conventional Syringe Irrigation | Procedure | Final irrigation was performed using syringe irrigation with 2.5% NaOCl and 17% EDTA solutions, without any activation. |
|
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D014098 | Toothache |
| D010485 | Periapical Periodontitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010518 | Periodontitis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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