- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917642
Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
July 2, 2018 updated by: Ericka Tavares Pinheiro, University of Sao Paulo
Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Passive Ultrasonic Irrigation Protocol
ultrasonic activation of antimicrobial solutions
|
Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file
|
Active Comparator: Non-Ultrasonic Irrigation Protocol
no-activation of antimicrobial solutions
|
Syringe and needle irrigation with no-ultrasonic activation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacterial Levels
Time Frame: 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
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endotoxin Levels
Time Frame: Through study completion, an average of 2 years
|
Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Giulio Gavini, DDS, Ms, PhD, Department of Dentistry, School of Dentistry, University of São Paulo.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 15, 2016
First Submitted That Met QC Criteria
September 26, 2016
First Posted (Estimate)
September 28, 2016
Study Record Updates
Last Update Posted (Actual)
July 3, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAPESP2013/02923-9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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