Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial) (CHITO-PRE RCT)

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

Study Overview

• Status: Recruiting
• Conditions: Apical Periodontitis; Dental Pulp Necrosis; Root Canal Infection
• Intervention / Treatment: Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Sodium Hypochlorite; Drug: EDTA chelating agents

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Dagci, Research Assistant; Phone Number: +905314275695; Email: dagci.esra.496@gmail.com

Study Locations

• Turkey
  • Altınordu
    • Ordu, Altınordu, Turkey, 52200
      • Recruiting
      • Ordu University
      • Contact: Esra Dagci, Research Assistant; Phone Number: +905314275695; Email: dagci.esra.496@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chitosan irrigation; Root canal irrigated with 0.2 % chitosan.	Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); 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
Experimental: NaOCl and Chitosan irrigation; Root canal irrigated with 10 mL of 2.5 % sodium hypochlorite (60 s contact), followed by 10 mL of 0.2 % chitosan solution (60 s contact). Final flush with 5 mL sterile saline	Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); 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; Drug: Sodium Hypochlorite; 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
Experimental: NaOCl and EDTA irrigation; Root canal irrigated with 10 mL of 2.5 % sodium hypochlorite (60 s contact), followed by 10 mL of 17 % EDTA solution (60 s contact). Final flush with 5 mL sterile saline.	Drug: Sodium Hypochlorite; 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; Drug: EDTA chelating agents; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intracanal Bacterial Load	Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation	Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"

Collaborators and Investigators

• Sponsor: ESRA DAĞCI
• Investigators: Principal Investigator: Fatih Cakici, DDS, PhD, Ordu University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): November 17, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: June 24, 2025
• First Submitted That Met QC Criteria: June 24, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Necrosis; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Sequestering Agents; Disinfectants; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Chelating Agents; Sodium Hypochlorite; Eusol; Chitosan
• Other Study ID Numbers: 2025000117-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level log10 CFU/mL data (baseline and immediate post-instrumentation) will be available 12 months after publication. Researchers may request the dataset by emailing the Principal Investigator; a data-sharing agreement will be required.
• IPD Sharing Time Frame: Beginning 12 months after primary publication and ending 5 years after publication

IPD Sharing Access Criteria

Access to the de-identified participant-level log10 CFU/mL dataset (baseline and immediate post-instrumentation) will be granted to qualified, non-commercial academic investigators.

Requests must include a brief research proposal and proof of institutional ethics approval, and should be e-mailed to the Principal Investigator (dagci.esra.496@gmail.com). After approval and signature of a data-sharing agreement that prohibits re-identification or further redistribution, the dataset and data dictionary will be transferred via a secure, password-protected file-sharing service.

No clinical charts, radiographs, consent forms, or ethics-committee documents will be shared. Data will be available beginning 12 months after primary publication, with no end date.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No