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Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this clinical trial is to learn which of three common root-canal rinsing (irrigation) methods removes bacteria most effectively in adult patients who need root-canal treatment. The main questions it will answer are:

How much does a chitosan solution used alone lower the number of bacteria inside the root canal? Do the combinations sodium hypochlorite + chitosan or sodium hypochlorite + EDTA lower bacteria even more than chitosan alone? Researchers will compare the three irrigation methods to see which one achieves the greatest bacterial reduction.

What participants will do

Be randomly assigned to one of three groups:

Group 1: Chitosan only Group 2: Sodium hypochlorite followed by chitosan Group 3: Sodium hypochlorite followed by EDTA

Attend two clinic visits:

Visit 1:

Receive standard root-canal treatment under local anesthesia. Provide tiny paper-point samples from inside the canal before and after the assigned rinse (painless; takes seconds).

Visit 2 (about 1 week later):

Return for a check-up and final filling of the tooth. Record any pain or discomfort for the first three days after treatment in a simple diary (or by phone).

About 90 adults will take part. All procedures are routine in dental care, and there is no cost to participate. Participants may withdraw at any time and can ask the study dentist any questions throughout the trial.

Eligibility

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

Study details
    Apical Periodontitis
    Dental Pulp Necrosis
    Root Canal Infection

NCT07048028

ESRA DAĞCI

17 July 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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