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

Not Applicable

Completed

• Conditions: Tooth, Nonvital
• Interventions: Device: Ultrasonic Irrigation; Device: Non-Ultrasonic Irrigation

• Registration Number: NCT02917642
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-07
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Study Completion: 2016-12
• Results First Submitted: 2018-05-02
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-02
• Last Update Submitted: 2018-07-02
• Results First Posted: 2018-07-03
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Teeth with necrotic pulps and asymptomatic apical periodontitis

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Passive Ultrasonic Irrigation Protocol	Ultrasonic Irrigation	ultrasonic activation of antimicrobial solutions
Non-Ultrasonic Irrigation Protocol	Non-Ultrasonic Irrigation	no-activation of antimicrobial solutions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Endotoxin Levels	Through study completion, an average of 2 years	Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay