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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Chitosan Low Molecular Weight (20-200 Mpa.S)
DrugA 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
DrugCommercial 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
DrugReady-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
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Chitosan irrigationExperimental treatment 1 intervention
Group B: NaOCl and Chitosan irrigationExperimental treatment 2 interventions
Group C: NaOCl and EDTA irrigationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Intracanal Bacterial Load
Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation
Time frame
Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ESRA DAĞCI
Lead sponsor
Ordu University
Sponsor institution
Source ClinicalTrials.gov