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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chitosan irrigation | Experimental | Root canal irrigated with 0.2 % chitosan. |
|
| NaOCl and Chitosan irrigation | Experimental | 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 |
|
| NaOCl and EDTA irrigation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitosan Low Molecular Weight (20-200 Mpa.S) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intracanal Bacterial Load | Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation | Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Dagci, Research Assistant | Contact | +905314275695 | dagci.esra.496@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatih Cakici, DDS, PhD | Ordu University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordu University | Recruiting | Ordu | Altınordu | 52200 | Turkey (Türkiye) |
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.
Beginning 12 months after primary publication and ending 5 years after publication
Access to the de-identified participant-level log10 CFU/mL dataset (baseline and immediate post-instrumentation) will be granted to qualified, non-commercial academic investigators.
Requests must include a brief research proposal and proof of institutional ethics approval, and should be e-mailed to the Principal Investigator (dagci.esra.496@gmail.com). After approval and signature of a data-sharing agreement that prohibits re-identification or further redistribution, the dataset and data dictionary will be transferred via a secure, password-protected file-sharing service.
No clinical charts, radiographs, consent forms, or ethics-committee documents will be shared. Data will be available beginning 12 months after primary publication, with no end date.
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
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|
| Sodium Hypochlorite | Drug | 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 |
|
| EDTA chelating agents | Drug | 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 |
|
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017601 |
| Oxygen Compounds |
| D017670 | Sodium Compounds |