Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorESRA DAĞCI

About this 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.

Eligibility criteria

Qualifiers

Patients who agreed to participate in the study

Systemically healthy patient

Mandibular premolar teeth

Teeth that respond negatively to thermal tests and EPT

Disqualifiers

Teeth with previous primary root-canal treatment

Pregnant patients

Severely curved roots (>25° curvature)

Canals with instrument separation during preparation

Trial design

Treatments tested in this trial

  • Chitosan Low Molecular Weight (20-200 Mpa.S)
  • Sodium Hypochlorite
  • EDTA chelating agents

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

ESRA DAĞCI

Lead sponsor

Ordu University

Sponsor institution