NCT06959602

Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial aims to evaluate the antibacterial efficacy and treatment outcomes of three different final irrigation protocols during root canal therapy: 2.5% sodium hypochlorite alone, sodium hypochlorite with Passive Ultrasonic Irrigation (PUI), and sodium hypochlorite with XP-Endo Finisher activation. Sixty-six single-rooted teeth with pulp necrosis and apical periodontitis will be randomly assigned to one of the three groups. Antibacterial efficacy will be assessed through Real-Time PCR quantification of total bacterial load and four specific bacterial species before and after treatment. Treatment success will be evaluated clinically and radiographically at 6 and 12 months. The study aims to identify the most effective irrigation strategy for bacterial reduction and healing outcomes.

Detailed description

This randomized, two-arm, parallel clinical trial investigates the antibacterial effectiveness and clinical outcomes of three root canal final irrigation protocols in teeth with pulp necrosis and apical periodontitis. Following standard chemomechanical preparation, participants' teeth will be randomly assigned to one of three interventions: final irrigation with 2.5% sodium hypochlorite alone, sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI) or sodium hypochlorite activated with the XP-Endo Finisher file. The study focuses on the reduction of total bacterial load and specific pathogenic bacterial species (Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porphyromonas endodontalis ) assessed through highly sensitive quantitative Real-Time PCR analysis of samples collected at different treatment stages. Sampling procedures ensure strict aseptic conditions and standardized protocols for DNA extraction and analysis. All participants will undergo a standardized endodontic treatment protocol by a single operator to minimize variability. Follow-up includes clinical and radiographic examinations at 6 and 12 months, with healing assessed through the Periapical Index (PAI) and presence or absence of clinical symptoms. This trial aims to provide new clinical evidence regarding the added value of supplementary irrigation techniques, comparing their ability to reduce bacterial burden and influence long-term treatment success.

Conditions

• Pulp Necrosis
• Apical Periodontitis
• Endodontic Treatment

Interventions

Type	Name	Description
PROCEDURE	Final Irrigation with 2.5% Sodium Hypochlorite	After supragingival scaling and removal of caries or defective restorations, the tooth will be isolated and disinfected with 3% H202 and 2.5% NaOCl. Access preparation will be done using a sterile high-speed bur under sterile saline irrigation, followed by re-disinfection. NaOCl will be neutralized with 5% sodium thiosulphate, and sterility will be confirmed via paper point sampling. Only teeth with negative sterility samples will proceed. Sample S1 will be collected after saline irrigation and mild instrumentation with a sterile K-file #15, using an apex locator. Paper points will absorb canal fluid and be frozen in Tris-EDTA buffer at -20°C. Complete chemomechanical preparation will follow, with irrigation after each instrument change. Cervical and mid-thirds will be enlarged with Gates-Glidden burs and the apical third with NiTi RaCe files (40/04). Sample S2 will be taken after preparation. Group A will receive final irrigation with 2.5% NaOCl before collection of sample S3.
PROCEDURE	Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite	Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).
PROCEDURE	XP-Endo Finisher Activation with Sodium Hypochlorite	Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-01
• Completion: 2025-10-31
• First posted: 2025-05-06
• Last updated: 2025-06-03

Locations

1 site across 1 country: Greece