Tooth, Nonvital
Conditions
Keywords
bacterial infection, endotoxin, passive ultrasonic irrigation, root canal treatment
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.
Interventions
DEVICEUltrasonic Irrigation
Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file
DEVICENon-Ultrasonic Irrigation
Syringe and needle irrigation with no-ultrasonic activation
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Levels | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endotoxin Levels | Through study completion, an average of 2 years | Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay |
Participant flow
Pre-assignment details
Patients who had received endodontic intervention or declined to participate before assignment: 16 out of 66 patients were excluded from this study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 25 |
| Non-Ultrasonic Irrigation Protocol no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation | 25 |
| Non-Ultrasonic Irrigation Protocol no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Non-Ultrasonic Irrigation Protocol | Total | Passive Ultrasonic Irrigation Protocol |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 50 Participants | 25 Participants |
| Age, Continuous | 34 years | 34 years | 38 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Brazil | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 20 Participants | 37 Participants | 17 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Bacterial Levels
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Passive Ultrasonic Irrigation Protocol | Bacterial Levels | 4290 DNA copies |
| Non-Ultrasonic Irrigation Protocol | Bacterial Levels | 10800 DNA copies |
Comparison: The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
Endotoxin Levels
Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay
Time frame: Through study completion, an average of 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Passive Ultrasonic Irrigation Protocol | Endotoxin Levels | 6.53 EU/mL |
| Non-Ultrasonic Irrigation Protocol | Endotoxin Levels | 5.75 EU/mL |
Comparison: The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.p-value: 0.94Wilcoxon (Mann-Whitney)