Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

NCT07048028 | Recruiting

• 1 other identifier: 2025000117-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Apical Periodontitis; Dental Pulp Necrosis; Root Canal Infection

Outcome Measures

Primary Outcomes (1)

• 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)"

Study Arms (3)

Chitosan irrigation

EXPERIMENTAL

Root canal irrigated with 0.2 % chitosan.

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

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.

Drug: Sodium Hypochlorite; Drug: EDTA chelating agents

Interventions

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

Chitosan irrigation; NaOCl and Chitosan irrigation

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

NaOCl and Chitosan irrigation; NaOCl and EDTA irrigation

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

NaOCl and EDTA irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Teeth with previous primary root-canal treatment
• Pregnant patients
• Severely curved roots (\>25° curvature)
• Canals with instrument separation during preparation
• Calcified (obliterated) canals

Sponsors & Collaborators

• ESRA DAĞCI: lead

Study Sites (1)

Ordu University

Ordu, Altınordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Fatih Cakici, DDS, PhD

  Ordu University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Dagci, Research Assistant

CONTACT

+905314275695; dagci.esra.496@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Esra Dagci

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: May 5, 2025
• Primary Completion: November 17, 2025
• Study Completion: December 12, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months after primary publication and ending 5 years after publication
• Access Criteria: 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.

Locations

TU (1)