Apical PeriodontitisCHITO-PRE RCTNCT07048028
Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)
A study testing Chitosan Low Molecular Weight (20-200 Mpa.S), Sodium Hypochlorite and EDTA chelating agents in people with Apical Periodontitis and Dental Pulp Necrosis, run by ESRA DAĞCI at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apical Periodontitis, Dental Pulp Necrosis, Root Canal Infection
- What is being tested?
- Chitosan Low Molecular Weight (20-200 Mpa.S), Sodium Hypochlorite and EDTA chelating agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who agreed to participate in the study
- Systemically healthy patient
- Mandibular premolar teeth
- Teeth that respond negatively to thermal tests and EPT
- Patients who have not used antibiotics for at least 2 weeks
Who cannot join
- Teeth with previous primary root-canal treatment
- Pregnant patients
- Severely curved roots (>25° curvature)
- Canals with instrument separation during preparation
- Calcified (obliterated) canals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ordu University
Ordu, Altınordu, 52200
Esra Dagci, Research Assistant, +905314275695, dagci.esra.496@gmail.com
About this study
Official title: Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical 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.
Read more
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.
- Being tested
- Chitosan Low Molecular Weight (20-200 Mpa.S), Sodium Hypochlorite, EDTA chelating agents
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Sodium HypochloriteDrug
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 agentsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Chitosan irrigation | Experimental | Root canal irrigated with 0.2 % chitosan. Receives: Drug: Chitosan Low Molecular Weight (20-200 Mpa.S) |
| 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 Receives: Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Sodium Hypochlorite |
| 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. Receives: Drug: Sodium Hypochlorite; Drug: EDTA chelating agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intracanal Bacterial Load
Change in Intracanal Bacterial Load (log10 CFU/mL) From Baseline to Immediate Post-instrumentation
Measured: Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start5 May 2025
- Primary completion17 Nov 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ESRA DAĞCI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ESRA DAĞCI, Ordu University
- Investigators
- Fatih Cakici, DDS, PhD, Principal investigator, Ordu University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048028
- Sponsor's protocol ID
- 2025000117-1
- Acronym
- CHITO-PRE RCT
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antibacterial Efficacy of Chitosan as an Irrigation Solution: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07048028
- Acronym / sponsor ID
- CHITO-PRE RCT / 2025000117-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ESRA DAĞCIUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 17 Nov 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chitosan irrigation | Experimental | Drug: Chitosan Low Molecular Weight (20-200 Mpa.S)Root canal irrigated with 0.2 % chitosan. |
| NaOCl and Chitosan irrigation | Experimental | Drug: Chitosan Low Molecular Weight (20-200 Mpa.S), Drug: Sodium HypochloriteRoot 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 | Drug: Sodium Hypochlorite, Drug: EDTA chelating agentsRoot 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who agreed to participate in the study
- Systemically healthy patient
- Mandibular premolar teeth
- Teeth that respond negatively to thermal tests and EPT
- Patients who have not used antibiotics for at least 2 weeks
Key exclusion criteria (5 listed)
- Teeth with previous primary root-canal treatment
- Pregnant patients
- Severely curved roots (>25° curvature)
- Canals with instrument separation during preparation
- Calcified (obliterated) canals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan Low Molecular Weight (20-200 Mpa.S)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 | Drug | Chitosan irrigation, NaOCl and Chitosan irrigation |
| Sodium HypochloriteCommercial 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 | Drug | NaOCl and Chitosan irrigation, NaOCl and EDTA irrigation |
| EDTA chelating agentsReady-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 | Drug | NaOCl and EDTA irrigation |
Primary outcome
Change in Intracanal Bacterial Load
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatih Cakici, DDS, PhD principal investigator
Ordu University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan Low Molecular Weight (20-200 Mpa.S), Sodium Hypochlorite and EDTA chelating agents in people with Apical Periodontitis and Dental Pulp Necrosis, run by ESRA DAĞCI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Dagci, Research Assistant (+905314275695, dagci.esra.496@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intracanal Bacterial Load (time frame: Baseline (pre-instrumentation) to Immediate Post-instrumentation (sample processed ≤ 48 h)"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.