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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive Ultrasonic Irrigation Protocol | Experimental | ultrasonic activation of antimicrobial solutions |
|
| Non-Ultrasonic Irrigation Protocol | Active Comparator | no-activation of antimicrobial solutions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Irrigation | Device | Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endotoxin Levels | Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay | Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulio Gavini, DDS, Ms, PhD | Department of Dentistry, School of Dentistry, University of São Paulo. | Study Chair |
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Patients who had received endodontic intervention or declined to participate before assignment: 16 out of 66 patients were excluded from this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Passive Ultrasonic Irrigation Protocol | ultrasonic activation of antimicrobial solutions Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file |
| FG001 | Non-Ultrasonic Irrigation Protocol | no-activation of antimicrobial solutions Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Passive Ultrasonic Irrigation Protocol | ultrasonic activation of antimicrobial solutions Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file |
| BG001 | Non-Ultrasonic Irrigation Protocol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Levels | Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay | Posted | Median | Full Range | DNA copies | Through study completion, an average of 2 years |
|
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed because the endodontic treatment does not cause mortality or serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Passive Ultrasonic Irrigation Protocol | ultrasonic activation of antimicrobial solutions Ultrasonic Irrigation: Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ericka T. Pinheiro | University of São Paulo | 551126488293 | erickapinheiro@usp.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2016 | May 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019553 | Tooth, Nonvital |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D001423 | Bacterial Infections and Mycoses |
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| Non-Ultrasonic Irrigation | Device | Syringe and needle irrigation with no-ultrasonic activation |
|
no-activation of antimicrobial solutions Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation |
| BG002 | Total | Total of all reporting groups |
| teeth |
|
| Participants |
| Participants |
|
|
| Age, Continuous | Median | Full Range | years | Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
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|
|
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| Secondary | Endotoxin Levels | Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay | Posted | Median | Full Range | EU/mL | Through study completion, an average of 2 years |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Non-Ultrasonic Irrigation Protocol | no-activation of antimicrobial solutions Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation | 0 | 0 | 0 | 0 |
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| D007239 | Infections |