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

ESRA DAĞCI

Status: Enrolling

Conditions: Apical Periodontitis; Root Canal Infection; Dental Pulp Necrosis

Treatments: Drug: Sodium Hypochlorite; Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: EDTA chelating agents

Study type: Interventional

Funder types: Other

Identifiers

NCT07048028

2025000117-1

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Chitosan irrigation

Experimental group

Description:

Root canal irrigated with 0.2 % chitosan.

Treatment:

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

NaOCl and Chitosan irrigation

Experimental group

Description:

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

Treatment:

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

Drug: Sodium Hypochlorite

NaOCl and EDTA irrigation

Experimental group

Description:

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.

Treatment:

Drug: EDTA chelating agents

Drug: Sodium Hypochlorite