An interventional study of Final Irrigation with 2.5% Sodium Hypochlorite and Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite in Pulp Necrosis, Apical Periodontitis and Endodontic Treatment, sponsored by National and Kapodistrian University of Athens. Enrolling by invitation at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Treatment
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.
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.
156 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 66 is above the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Root canals will be irrigated with 2.5% sodium hypochlorite as the final irrigation without activation.
Procedure: Final Irrigation with 2.5% Sodium Hypochlorite
Root canals will be irrigated with 2.5% sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI).
Procedure: Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite
Root canals will be irrigated with 2.5% sodium hypochlorite followed by mechanical activation using the XP-Endo Finisher file.
Procedure: XP-Endo Finisher Activation with 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.
Also known as: NaOCl 2.5%
Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).
Also known as: PUI; Ultrasonic Activation; Passive Ultrasonic Irrigation
Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).
Also known as: XP-Endo Finisher; XPF Activation
Reduction in Total Intracanal Bacterial Load
Quantitative reduction of the total intra canal bacterial load measured by Real-Time PCR (qPCR) after final irrigation procedures.
Time frame: 0ne to six months
Reduction in Specific Bacterial Species
Quantitative change of Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porpyromonas endodontalis measured by Real-Time PCR after supplementary irrigation procedures.
Time frame: one to six months
Clinical and Radiographic Healing Outcome
Healing of periapical lesions assessed clinically and radiographically (using the Periapical Index, PAI) at 6 and 12 months after treatment.
Time frame: 6 months and 12 months after root canal treatment
Comparison of Antibacterial Effectiveness Between Interventions
Comparison of the bacterial load reduction and treatment success rates among the three irrigation strategies.
Time frame: Immediately post-treatment and at 12 months follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The IPD that will be shared include anonymized data related to the bacterial load measurements (qPCR results for total bacterial load and for Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porphyromonas endodontalis), treatment group allocation (NaOCl 2.5% only, NaOCl 2.5% + Passive Ultrasonic Irrigation (PUI), or NaOCl 2.5% + XP Endo Finisher), and treatment outcomes based on clinical and radiographic follow-up (e.g., PAI scores, presence/absence of clinical signs and symptoms). No data containing directly identifiable patient information (e.g., names, personal identification numbers) will be shared. The data will be available upon reasonable request to the principal investigator after the publication of the study results, with the requirement of a data-sharing agreement to ensure appropriate use. The sharing will comply with ethical approvals and participants' consent agreements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The individual participant data (IPD) and supporting documents will become available starting 6 months after the publication of the main study results. Data will be available for a minimum of 5 years thereafter.
Access criteria: Researchers who provide a methodologically sound research proposal and agree to a data-sharing agreement will be eligible to access the data. Proposals will be reviewed by the study's advisory committee to ensure they are appropriate and ethical. Access will be granted for academic, non-commercial research purposes only. Data will be provided through a secure platform ensuring confidentiality and data protection.
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