Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07048028

Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical Trial

Led by ESRA DAĞCI · Updated on 2025-07-04

90

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating which of three common root-canal rinsing methods best reduces bacteria in adults needing root-canal treatment. The study focuses on whether chitosan alone, sodium hypochlorite combined with chitosan, or sodium hypochlorite combined with EDTA achieves the greatest bacterial reduction inside the root canal. This randomized controlled trial aims to provide clearer information on effective irrigation solutions for dental infections like apical periodontitis and root canal infection. Participants are randomly assigned to one of three groups: chitosan irrigation only; sodium hypochlorite followed by chitosan; or sodium hypochlorite followed by EDTA. Each solution is delivered into the root canal with specific contact times and followed by a sterile saline flush. Treatment takes place over two clinic visits: the first involves standard root-canal therapy with sample collection before and after rinsing, and the second visit, about a week later, is for a check-up and final tooth filling. Participants will provide tiny samples from inside the root canal for bacterial measurement before and immediately after treatment. They will also record any pain or discomfort for three days post-treatment using a diary or phone calls. The main outcome measured is the change in bacterial load inside the canal from before to after treatment. The study lasts about one week, involves approximately 90 adults, and all procedures are routine dental care provided at no cost. Participants may withdraw at any time and can ask questions throughout the trial.

CONDITIONS

Brief Title

Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Teeth with previous primary root-canal treatment
  • Pregnant patients
  • Severely curved roots (>25° curvature)
  • Canals with instrument separation during preparation
  • Calcified (obliterated) canals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single treatment session

Participants receive root canal irrigation with one of the study solutions: 0.2% chitosan, a combination of sodium hypochlorite and chitosan, or sodium hypochlorite followed by EDTA. The irrigation involves specific volumes and contact times during the procedure.

1 treatment visit (in-person)

Trial Site Locations

Total: 1 location

1

Ordu University

Ordu, Altınordu, Turkey (Türkiye), 52200

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Research Team

E

Esra Dagci, Research Assistant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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