Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods

Not Applicable

• Conditions: Pulp Necrosis; Apical Periodontitis; Endodontic Treatment

• Registration Number: NCT06959602
• Lead Sponsor: National and Kapodistrian University of Athens

Brief 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.

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Primary Completion: 2025-04-30
• Status Verified: 2025-05
• Study First Posted: 2025-05-06
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Informed consent by the patients who wish to participate in the study.
• Single-rooted teeth with pulp necrosis confirmed by pulp sensibility tests, negative response to both cold and electric pulp testing and radiographic evidence of apical periodontitis.
• Teeth with relatively straight canals, complete root development and no radiographic evidence of pulp canal obliteration.

Exclusion Criteria

• Patients who have received antibiotic treatment the last 3 months or need chemoprophylaxis for dental treatment.
• Teeth with previous endodontic treatment.
• Teeth with cracks or incomplete vertical root fracture which disturbs the integrity of the pulp chamber walls or teeth with the pulp chamber exposed to oral environment.
• Teeth with periodontal pocket more than 4mm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Total Intracanal Bacterial Load	0ne to six months	Quantitative reduction of the total intra canal bacterial load measured by Real-Time PCR (qPCR) after final irrigation procedures.

Secondary Outcome Measures

Name	Time	Method
Reduction in Specific Bacterial Species	one to six months	Quantitative change of Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porpyromonas endodontalis measured by Real-Time PCR after supplementary irrigation procedures.
Clinical and Radiographic Healing Outcome	6 months and 12 months after root canal treatment	Healing of periapical lesions assessed clinically and radiographically (using the Periapical Index, PAI) at 6 and 12 months after treatment.

Trial Locations

Locations (1)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece