An interventional study of Chitosan Low Molecular Weight (20-200 Mpa.S) and Sodium Hypochlorite in Apical Periodontitis, Dental Pulp Necrosis and Root Canal Infection, sponsored by ESRA DAĞCI. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by ESRA DAĞCI · Not applicable, Interventional, and Treatment
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.
245 studies on the registry are indexed under Periapical Periodontitis; 64 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 210 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →This is the only study on the registry with ESRA DAĞCI as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Root canal irrigated with 0.2 % chitosan.
Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)
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
Drug: Chitosan Low Molecular Weight (20-200 Mpa.S) · Drug: Sodium Hypochlorite
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.
Drug: Sodium Hypochlorite · Drug: EDTA chelating agents
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
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)"
Plan to share: Yes — De-identified participant-level log10 CFU/mL data (baseline and immediate post-instrumentation) will be available 12 months after publication. Researchers may request the dataset by emailing the Principal Investigator; a data-sharing agreement will be required.
Supporting information: Study protocol
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