Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
Clinical Evaluation of the Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 15, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
July 3, 2018
CompletedJuly 3, 2018
July 1, 2018
2.5 years
September 15, 2016
May 2, 2018
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bacterial Levels
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 Outcomes (1)
Endotoxin Levels
Through study completion, an average of 2 years
Study Arms (2)
Passive Ultrasonic Irrigation Protocol
EXPERIMENTALultrasonic activation of antimicrobial solutions
Non-Ultrasonic Irrigation Protocol
ACTIVE COMPARATORno-activation of antimicrobial solutions
Interventions
Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file
Syringe and needle irrigation with no-ultrasonic activation
Eligibility Criteria
You may qualify if:
- Teeth with necrotic pulps and asymptomatic apical periodontitis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ericka T. Pinheiro
- Organization
- University of São Paulo
Study Officials
- STUDY CHAIR
Giulio Gavini, DDS, Ms, PhD
Department of Dentistry, School of Dentistry, University of São Paulo.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 15, 2016
First Posted
September 28, 2016
Study Start
January 1, 2014
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
July 3, 2018
Results First Posted
July 3, 2018
Record last verified: 2018-07