Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Official title

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

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.

Interventions

• 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
• 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

Primary outcome measures

• Change in Intracanal Bacterial Load [Time frame: Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ordu University — Ordu

Identifiers

NCT: NCT07048028 · 2025000117-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗