Ordu University
Ordu, Altınordu, 52200, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07048028
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ordu, Altınordu, 52200, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"
Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation
Contact information is provided by the study sponsor or research team.
ESRA DAĞCI
Other
Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical Trial
Acronym: CHITO-PRE RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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