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NCT03668899

Antimicrobial Efficacy of Four Different Irrigation Protocols

Completed NA Results posted Last updated 29 June 2025
What this trial tests

NA trial testing irrigation in Dental Pulp Necrosis in 60 participants. Completed in 15 August 2020.

Timeline
25 January 2020
Primary endpoint
30 April 2020
15 August 2020

Quick facts

Lead sponsorCairo University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date25 January 2020
Primary completion30 April 2020
Estimated completion15 August 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

Adults 22 to 45, any sex, with Dental Pulp Necrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Colony Forming Units Per Millilitre Primary · 1 week after culture

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

preoperative measurements
GroupValue95% CI
Chitosan NPs Group8030000068900000 – 94100000
Chlorhexidine Group7990000069700000 – 91400000
Combination Group7400000051200000 – 96000000
Hypochlorite Group7300000062700000 – 92400000
postoperative measurements
GroupValue95% CI
Chitosan NPs Group7700052000 – 108000
Chlorhexidine Group12400083000 – 161000
Combination Group8800041000 – 104000
Hypochlorite Group8900051000 – 149000
Numerical Rating Scale Secondary · after 6 hours,12 hours, 24 hours, 48 hours, 72 hours and 7 days postoperatively

pain 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"

preoperative pain
GroupValue95% CI
Chlorhexidine Group7
Chitosan NPs Group8
Combination Group6
Hypochlorite Group7
Chlorhexidine Group8
Chitosan NPs Group7
Combination Group9
Hypochlorite Group8
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
postoperative pain after 6 hours
GroupValue95% CI
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group2
Hypochlorite Group2
Chlorhexidine Group12
Chitosan NPs Group10
Combination Group10
Hypochlorite Group8
Chlorhexidine Group3
Chitosan NPs Group5
Combination Group3
Hypochlorite Group5
postoperative pain after 12 hours
GroupValue95% CI
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group7
Chitosan NPs Group0
Combination Group8
Hypochlorite Group3
Chlorhexidine Group7
Chitosan NPs Group12
Combination Group6
Hypochlorite Group11
Chlorhexidine Group1
Chitosan NPs Group3
Combination Group1
Hypochlorite Group1
postoperative pain after 24 hours
GroupValue95% CI
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group12
Chitosan NPs Group11
Combination Group13
Hypochlorite Group12
Chlorhexidine Group3
Chitosan NPs Group4
Combination Group2
Hypochlorite Group3
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
postoperative pain after 48 hours
GroupValue95% CI
Chlorhexidine Group7
Chitosan NPs Group7
Combination Group10
Hypochlorite Group11
Chlorhexidine Group8
Chitosan NPs Group8
Combination Group5
Hypochlorite Group4
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
postoperative pain after 72 hours
GroupValue95% CI
Chlorhexidine Group13
Chitosan NPs Group10
Combination Group12
Hypochlorite Group11
Chlorhexidine Group2
Chitosan NPs Group5
Combination Group3
Hypochlorite Group4
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0
postoperative pain after 7 days
GroupValue95% CI
Chlorhexidine Group13
Chitosan NPs Group14
Combination Group12
Hypochlorite Group13
Chlorhexidine Group2
Chitosan NPs Group0
Combination Group3
Hypochlorite Group2
Chlorhexidine Group0
Chitosan NPs Group1
Combination Group0
Hypochlorite Group0
Chlorhexidine Group0
Chitosan NPs Group0
Combination Group0
Hypochlorite Group0

Sponsor's own description

proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic pulps in their mandibular posterior teeth. patients will be recruited from outpatient clinic of the endodontic department in cairo university. endodontic treatment will be carried out as usual and samples from the infected root canals will be collected before and after preparation to be cultivated and analyzed at the laboratories of microbiology of faculty of medicine, cairo university

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Dental Pulp Necrosis

Currently open trials in the same condition.

Other Cairo University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03668899.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing