Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals

Study Overview
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Brief Summary
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The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide [LPS]) from root canals.

Detailed Description
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Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.

Official Title
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Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals

Conditions
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Tooth, Nonvital

Intervention / Treatment
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* Device: Ultrasonic Irrigation
* Device: Non-Ultrasonic Irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Teeth with necrotic pulps and asymptomatic apical periodontitis Exclusion Criteria: patients who had received antibiotics during the previous 3 months or had any general disease, teeth that could not be properly isolated with rubber dam, non-restored teeth, periodontal pockets depths greater than 4 mm, previous endodontic treatment, open apex, crown/root fracture root resorption or calcifications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive Ultrasonic Irrigation Protocol<br>ultrasonic activation of antimicrobial solutions | Device: Ultrasonic Irrigation<br>* Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file<br>|
| Active Comparator: Non-Ultrasonic Irrigation Protocol<br>no-activation of antimicrobial solutions | Device: Non-Ultrasonic Irrigation<br>* Syringe and needle irrigation with no-ultrasonic activation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Levels | Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotoxin Levels | Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment