Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

NCT ID: NCT07048028

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-12-12

Brief Summary

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.

Conditions

Apical Periodontitis; Dental Pulp Necrosis; Root Canal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chitosan irrigation

Root canal irrigated with 0.2 % chitosan.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Sodium Hypochlorite

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ESRA DAĞCI

OTHER

Sponsor Role: lead

Responsible Party

ESRA DAĞCI

Research Assistant Esra Dagci

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fatih Cakici, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Ordu University Faculty of Dentistry

Locations

Ordu University

Ordu, Altınordu, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Esra Dagci, Research Assistant

Role: CONTACT

dagci.esra.496@gmail.com

+905314275695

Facility Contacts

Esra Dagci, Research Assistant

Role: primary

dagci.esra.496@gmail.com

+905314275695

Other Identifiers

2025000117-1

Identifier Type: -

Identifier Source: org_study_id