Chitosan irrigation for mandibular premolar root canal treatment
Official title: Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical Trial
Run by Ordu University · NCT07048028 · Data updated 2026-11-12
This test compares three common root-canal rinses to see which one best reduces bacteria in adults needing a premolar root canal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Ordu University Academic / other |
| Locations | 1 site (Ordu, Altınordu) |
| Status | Recruiting |
| Started | May 5, 2025 |
| Main results expected | November 17, 2025 |
| Study ends | December 12, 2025 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT07048028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who are systemically healthy, not pregnant, have a mandibular premolar with non-vital pulp (negative thermal/EPT) and no recent antibiotic use are the ideal candidates.
✕Probably not a fit
Patients with previously treated root canals, severely curved or calcified canals, instrument separation during preparation, pregnant patients, or those recently on antibiotics would not qualify and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized interventional trial adults with necrotic mandibular premolars and signs of apical periodontitis are assigned to one of three irrigation methods: chitosan alone, sodium hypochlorite followed by chitosan, or sodium hypochlorite followed by EDTA. During the first visit participants receive standard root canal treatment under local anesthesia and brief, painless paper-point samples are taken from inside the canal before and after the assigned rinse to measure bacterial load. Participants return for a second follow-up visit about one week later per the protocol. The primary outcome is reduction in intracanal bacterial counts comparing the three irrigation regimens.
Why it matters
Potential benefit: If successful, the trial could identify a rinsing regimen that more effectively reduces bacteria during root canal treatment, which may improve treatment success and lower the chance of persistent infection.
How similar studies have gone: Smaller laboratory and clinical studies have reported antimicrobial effects for chitosan and synergy with sodium hypochlorite, but large randomized clinical evidence comparing these specific protocols is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who agreed to participate in the study * Systemically healthy patient * Mandibular premolar teeth * Teeth that respond negatively to thermal tests and EPT * Patients who have not used antibiotics for at least 2 weeks Exclusion Criteria: * Teeth with previous primary root-canal treatment * Pregnant patients * Severely curved roots (\>25° curvature) * Canals with instrument separation during preparation * Calcified (obliterated) canals
Where it's running
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Ordu University
Ordu, Altınordu, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Fatih Cakici, DDS, PhD — Ordu University Faculty of Dentistry
- Study coordinator: Esra Dagci, Research Assistant
- Email: dagci.esra.496@gmail.com
- Phone: +905314275695
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.