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NCT Number: NCT07048028

Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Esra Dagci, Research Assistant

CONTACT

[email protected]

+905314275695

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chitosan Low Molecular Weight (20-200 Mpa.S)

Drug

A 0.2 % (w/v) low-molecular-weight chitosan solution (50-190 kDa, ≥75 % deacetylation) prepared fresh in 1 % acetic acid, pH ≈ 6.0. Ten mL is delivered into the root canal over 30 s and left in situ for an additional 30 s (total contact 60 s), followed by a 5 mL sterile saline flush

Sodium Hypochlorite

Drug

Commercial 2.5 % (w/v) sodium hypochlorite endodontic irrigant. Ten mL is delivered over 30 s and left for 30 s (total contact 60 s), then flushed with 5 mL sterile saline

EDTA chelating agents

Drug

Ready-to-use 17 % EDTA solution (pH ≈ 7.3) for smear-layer removal. Ten mL is delivered over 30 s and left for 30 s (total contact 60 s), then flushed with 5 mL sterile saline

Primary outcomes

  1. Change in Intracanal Bacterial Load

    Time frame: Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"

    Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Dagci, Research Assistant

CONTACT

[email protected]

+905314275695

Sponsors and collaborators

Lead sponsor

ESRA DAĞCI

Other

Registry information

Official study title

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

Acronym: CHITO-PRE RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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