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

Primary Purpose

Tooth, Nonvital

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasonic Irrigation
Non-Ultrasonic Irrigation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Nonvital focused on measuring bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Passive Ultrasonic Irrigation Protocol

    Non-Ultrasonic Irrigation Protocol

    Arm Description

    ultrasonic activation of antimicrobial solutions

    no-activation of antimicrobial solutions

    Outcomes

    Primary Outcome Measures

    Bacterial Levels
    Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay

    Secondary Outcome Measures

    Endotoxin Levels
    Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay

    Full Information

    First Posted
    September 15, 2016
    Last Updated
    July 2, 2018
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02917642
    Brief Title
    Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
    Official Title
    Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth, Nonvital
    Keywords
    bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Passive Ultrasonic Irrigation Protocol
    Arm Type
    Experimental
    Arm Description
    ultrasonic activation of antimicrobial solutions
    Arm Title
    Non-Ultrasonic Irrigation Protocol
    Arm Type
    Active Comparator
    Arm Description
    no-activation of antimicrobial solutions
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasonic Irrigation
    Intervention Description
    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
    Intervention Name(s)
    Non-Ultrasonic Irrigation
    Intervention Description
    Syringe and needle irrigation with no-ultrasonic activation
    Primary Outcome Measure Information:
    Title
    Bacterial Levels
    Description
    Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
    Time Frame
    Through study completion, an average of 2 years
    Secondary Outcome Measure Information:
    Title
    Endotoxin Levels
    Description
    Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay
    Time Frame
    Through study completion, an average of 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giulio Gavini, DDS, Ms, PhD
    Organizational Affiliation
    Department of Dentistry, School of Dentistry, University of São Paulo.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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