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NCT Number: NCT06959602

Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National and Kapodistrian University of Athens

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Final Irrigation with 2.5% Sodium Hypochlorite

Procedure

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.

Other names: NaOCl 2.5%

Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite

Procedure

Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).

Other names: PUI; Ultrasonic Activation; Passive Ultrasonic Irrigation

XP-Endo Finisher Activation with Sodium Hypochlorite

Procedure

Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).

Other names: XP-Endo Finisher; XPF Activation

Primary outcomes

  1. Reduction in Total Intracanal Bacterial Load

    Time frame: 0ne to six months

    Quantitative reduction of the total intra canal bacterial load measured by Real-Time PCR (qPCR) after final irrigation procedures.

Secondary outcomes

  1. Reduction in Specific Bacterial Species

    Time frame: 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.

  2. Clinical and Radiographic Healing Outcome

    Time frame: 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.

Other outcomes

  1. Comparison of Antibacterial Effectiveness Between Interventions

    Time frame: Immediately post-treatment and at 12 months follow-up

    Comparison of the bacterial load reduction and treatment success rates among the three irrigation strategies.

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Acronym: ENDOABG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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