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

NCT ID: NCT02917642

Last Updated: 2018-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

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.

Conditions

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Tooth, Nonvital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Passive Ultrasonic Irrigation Protocol

ultrasonic activation of antimicrobial solutions

Group Type EXPERIMENTAL

Ultrasonic Irrigation

Intervention Type DEVICE

Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file

Non-Ultrasonic Irrigation Protocol

no-activation of antimicrobial solutions

Group Type ACTIVE_COMPARATOR

Non-Ultrasonic Irrigation

Intervention Type DEVICE

Syringe and needle irrigation with no-ultrasonic activation

Interventions

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Ultrasonic Irrigation

Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file

Intervention Type DEVICE

Non-Ultrasonic Irrigation

Syringe and needle irrigation with no-ultrasonic activation

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ericka Tavares Pinheiro

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giulio Gavini, DDS, Ms, PhD

Role: STUDY_CHAIR

Department of Dentistry, School of Dentistry, University of São Paulo.

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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FAPESP2013/02923-9

Identifier Type: -

Identifier Source: org_study_id

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