Trial Outcomes & Findings for Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals (NCT NCT02917642)
NCT ID: NCT02917642
Last Updated: 2018-07-03
Results Overview
Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Through study completion, an average of 2 years
Results posted on
2018-07-03
Participant Flow
Patients who had received endodontic intervention or declined to participate before assignment: 16 out of 66 patients were excluded from this study.
Participant milestones
| Measure |
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
|
Non-Ultrasonic Irrigation Protocol
no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Passive Ultrasonic Irrigation Protocol
n=25 teeth
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
|
Non-Ultrasonic Irrigation Protocol
n=25 teeth
no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation
|
Total
n=50 teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
38 years
n=25 Participants
|
34 years
n=25 Participants
|
34 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
37 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
13 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 2 yearsQuantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay
Outcome measures
| Measure |
Passive Ultrasonic Irrigation Protocol
n=25 Participants
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
|
Non-Ultrasonic Irrigation Protocol
n=25 Participants
no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation
|
|---|---|---|
|
Bacterial Levels
|
4290 DNA copies
Interval 0.0 to 22200.0
|
10800 DNA copies
Interval 0.0 to 338000.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 yearsQuantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay
Outcome measures
| Measure |
Passive Ultrasonic Irrigation Protocol
n=22 Participants
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
|
Non-Ultrasonic Irrigation Protocol
n=23 Participants
no-activation of antimicrobial solutions
Non-Ultrasonic Irrigation: Syringe and needle irrigation with no-ultrasonic activation
|
|---|---|---|
|
Endotoxin Levels
|
6.53 EU/mL
Interval 0.0 to 19.4
|
5.75 EU/mL
Interval 0.0 to 14.8
|
Adverse Events
Passive Ultrasonic Irrigation Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Ultrasonic Irrigation Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place