Back to resultsEffect 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
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
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
NCT ID
NCT02917642
First Posted
September 15, 2016
Last Updated
July 2, 2018
Sponsor
University of Sao Paulo
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
Learn more about this trial
Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
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