Chitosan Irrigation in Premolar Root Canal Therapy (Randomized Trial)

Not Applicable

Recruiting

• Conditions: Apical Periodontitis; Dental Pulp Necrosis; Root Canal Infection
• Interventions: Drug: Chitosan Low Molecular Weight (20-200 Mpa.S); Drug: Sodium Hypochlorite; Drug: EDTA chelating agents

• Registration Number: NCT07048028
• Lead Sponsor: ESRA DAĞCI

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-05
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-04
• Primary Completion: 2025-11-17
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chitosan irrigation	Chitosan Low Molecular Weight (20-200 Mpa.S)	Root canal irrigated with 0.2 % chitosan.
NaOCl and Chitosan irrigation	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
NaOCl and Chitosan irrigation	Sodium Hypochlorite	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	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.
NaOCl and EDTA irrigation	EDTA chelating agents	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.

Primary Outcome Measures

Name	Time	Method
Change in Intracanal Bacterial Load	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

Trial Locations

Locations (1)

Ordu University; 🇹🇷 Ordu, Altınordu, Turkey