Trial Outcomes & Findings for Antimicrobial Efficacy of Four Different Irrigation Protocols (NCT NCT03668899)
NCT ID: NCT03668899
Last Updated: 2025-06-29
Results Overview
activity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 week after culture
Results posted on
2025-06-29
Participant Flow
Participant milestones
| Measure |
Chitosan NPs Group
irrigation with 3% Chitosan nano particles (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Chlorhexidine Group
irrigation with 2% CHX (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Combination Group
irrigation with 2% CHX/ 3%Chitosan nano particles combination (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Hypochlorite Group
irrigation with 5.25% NaOCL (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
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 |
Chitosan NPs Group
n=15 Participants
irrigation with 3% Chitosan nano particles (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Chlorhexidine Group
n=15 Participants
irrigation with 2% CHX (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Combination Group
n=15 Participants
irrigation with 2% CHX/ 3% Chitosan nano particles combination (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Hypochlorite Group
n=15 Participants
irrigation with 5.25% NaOCL (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
n=15 Participants
|
31 years
n=15 Participants
|
29 years
n=15 Participants
|
29 years
n=15 Participants
|
30 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
33 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
27 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 1 week after cultureactivity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is
Outcome measures
| Measure |
Chitosan NPs Group
n=15 Participants
irrigation with 3% Chitosan nano particles (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Chlorhexidine Group
n=15 Participants
irrigation with 2% CHX (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Combination Group
n=15 Participants
irrigation with 2% CHX/ 3%Chitosan nano particles combination (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Hypochlorite Group
n=15 Participants
irrigation with 5.25% NaOCL (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
|---|---|---|---|---|
|
Number of Colony Forming Units Per Millilitre
preoperative measurements
|
80300000 CFU/ml
Interval 68900000.0 to 94100000.0
|
79900000 CFU/ml
Interval 69700000.0 to 91400000.0
|
74000000 CFU/ml
Interval 51200000.0 to 96000000.0
|
73000000 CFU/ml
Interval 62700000.0 to 92400000.0
|
|
Number of Colony Forming Units Per Millilitre
postoperative measurements
|
77000 CFU/ml
Interval 52000.0 to 108000.0
|
124000 CFU/ml
Interval 83000.0 to 161000.0
|
88000 CFU/ml
Interval 41000.0 to 104000.0
|
89000 CFU/ml
Interval 51000.0 to 149000.0
|
SECONDARY outcome
Timeframe: after 6 hours,12 hours, 24 hours, 48 hours, 72 hours and 7 days postoperativelypain incidence and intensity after root canal treatment The NRS consists of an 11 points line anchored by two extremes "No pain" and "pain as bad as could be"
Outcome measures
| Measure |
Chitosan NPs Group
n=15 Participants
irrigation with 3% Chitosan nano particles (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Chlorhexidine Group
n=15 Participants
irrigation with 2% CHX (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Combination Group
n=15 Participants
irrigation with 2% CHX/ 3%Chitosan nano particles combination (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
Hypochlorite Group
n=15 Participants
irrigation with 5.25% NaOCL (final flush)
irrigation: irrigation of root canals during mechanical preparation for purposes of cleaning and disinfection
|
|---|---|---|---|---|
|
Numerical Rating Scale
preoperative pain · no pain
|
7 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Numerical Rating Scale
preoperative pain · mild pain
|
8 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
|
Numerical Rating Scale
preoperative pain · moderate pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
preoperative pain · severe pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 6 hours · no pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 6 hours · mild pain
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Numerical Rating Scale
postoperative pain after 6 hours · moderate pain
|
12 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
|
Numerical Rating Scale
postoperative pain after 6 hours · severe pain
|
3 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Numerical Rating Scale
postoperative pain after 12 hours · no pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 12 hours · mild pain
|
7 Participants
|
0 Participants
|
8 Participants
|
3 Participants
|
|
Numerical Rating Scale
postoperative pain after 12 hours · moderate pain
|
7 Participants
|
12 Participants
|
6 Participants
|
11 Participants
|
|
Numerical Rating Scale
postoperative pain after 12 hours · severe pain
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Numerical Rating Scale
postoperative pain after 24 hours · no pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 24 hours · mild pain
|
12 Participants
|
11 Participants
|
13 Participants
|
12 Participants
|
|
Numerical Rating Scale
postoperative pain after 24 hours · moderate pain
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Numerical Rating Scale
postoperative pain after 24 hours · severe pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 48 hours · no pain
|
7 Participants
|
7 Participants
|
10 Participants
|
11 Participants
|
|
Numerical Rating Scale
postoperative pain after 48 hours · mild pain
|
8 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Numerical Rating Scale
postoperative pain after 48 hours · moderate pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 48 hours · severe pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 72 hours · no pain
|
13 Participants
|
10 Participants
|
12 Participants
|
11 Participants
|
|
Numerical Rating Scale
postoperative pain after 72 hours · mild pain
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Numerical Rating Scale
postoperative pain after 72 hours · moderate pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 72 hours · severe pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 7 days · no pain
|
13 Participants
|
14 Participants
|
12 Participants
|
13 Participants
|
|
Numerical Rating Scale
postoperative pain after 7 days · mild pain
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Numerical Rating Scale
postoperative pain after 7 days · moderate pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Numerical Rating Scale
postoperative pain after 7 days · severe pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Chitosan NPs Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hypochlorite Group
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