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Active, Not Recruiting

NCT Number: NCT06949176

Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal

The aim of the study is first, to evaluate the clinical antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis by using Real-time PCR. . Second, to evaluate the efficacy of final irrigation by assessing, if possible, a numerical definition for that "so called" as "copious irrigation".

Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National and Kapodistrian University of Athens

Athens, 11527, Greece

About this study

The antibacterial efficacy of two different NaOCl concentrations (2,5% and 5%) under a predefined irrigant flow rate in teeth with pulp necrosis and apical periodontitis will be examined through the calculation of the total bacterial load before any treatment procedure and the possible bacteria reduction after each treatment procedure (chemomechanical preparation, and final irrigation treatments). In addition, the antimicrobial efficacy of the above two different concentrations of NaOCl will be compared in terms of treatment outcome. All patients will be asked for one-year recall examination where the outcome of endodontic treatment will be evaluated through clinical and radiographic examination. For the identification of the"copious irrigation" the total amount of final irrigation will be divided in two equal parts of volume/ time (15ml for 5 minutes each). Total bacterial load that will remain after chemomechanical preparation will be compared to the number of bacteria calculated after the first and the second part of irrigation. It will be investigated if final irrigation provides to further microbial reduction and whether prolonged irrigation augments the antibacterial effect.

Besides the total microbial load, the antibacterial efficacy of final irrigation procedure against two different bacterial species (namely Pseudoramibacter alactolyticus and Treponema denticola) will also be examined. First, the prevalence of these specific species will be investigated in primary endodontic infections in Greek-living population. In addition, the effect of chemomechanical preparation and final irrigation procedure on the number of these species will be relatively examined though the reduction curves that will be obtained by qPCR.

Who can participate

Healthy volunteers accepted: Yes

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 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.
  • Teeth with periodontal pocket more than 4mm.

Treatment and study plan

Root canal tratment using mecchanical and chemical preparation.

Procedure

Root canal procedures including access cavity preparation, chemomechanical instrumentation, irrigation with sodium hypoclorite (NaOCl), microbiological sampling and obturation with warm vertical compaction.

Other names: Endodontic thereapy.

Sodium Hypochlorite.

Drug

Sodium Hypoclorite used as the primary irrigant in the root canal treatment at concentrations of 2.5% (Group A) and 5% (Group B).

Other names: NaOCl

Hydrogen peroxide.

Drug

Applied to the operating field and tooth as part of initial disinfection prior to cavity access.

Other names: H202

Sodium Sulfate.

Drug

Used to inactivate sodium hypoclorite prior to sample collection.

Other names: Na2S2O3

Root ZX mini apex locator (Morita).

Device

Used to determine the working length of the root canal.

Other names: Morita apex locator.

Protaper Gold rotary files (Dentslpy Maillefer).

Device

Used for coronal flaring in root canal instrumentation.

Other names: Dentsply Maillefer rotary system.

Smarttrack and Hyflex totary files.

Device

Used for root canal instrumentation to full working length.

Other names: Nikinc and Coltene/Whaledent rotary systems.

Endo-Eze 27G irrigation needle (Ultradent).

Device

Used to deliver irrigant into the root canal.

Other names: 27G Luer Lock needle.

Primary outcomes

  1. Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl.

    Time frame: DAY 1: Immediately after chemomechanical preparation.

    Clinical antibacterial efficiency of two different NaOCl concentrations (2.5% and 5%) will be assessed by measuring the total bacteria load reduction using qPCR.

    The unit measure is the Log reduction in total Bacterial DNA copies per sample.

  2. Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl.

    Time frame: DAY 1: Immediately after final irrigation.

    Further reduction of total bacterial load after final irrigation using the same two NaOCl concentrations.

    he unit measure is the Log reduction in total Bacterial DNA copies per sample.

  3. Clinical and radiographic treatment success.

    Time frame: 1 year post tratment.

    Comparison of endodontic treatment outcome between the two NaOCl concentrations groups, assessed by clinical exam and periapical index (PAI).

    Unit measure: Number of teeth scored as healed PAI <2 vs not healed PAI>3.

    Scale Information:

    The Periapical Index (PAI) is a radiographic scoring system ranging from 1 to 5, where:

    1 = Normal periapical structures (best outcome) 5 = Severe periodontitis with exacerbating features (worst outcome) Lower scores indicate better healing.

Secondary outcomes

  1. Additional bacterial load reduction between two sequential 15 ml irrigation periods

    Time frame: Beteen 1 and 6 months after samples collection.

    Evaluation of "copious irrigation" effectiveness by measuring bacterial load after each of two equal 15 ml/5 min final irrigation stages.

    Unit of Measure: Log reduction in total bacterial DNA copies per sample

  2. Prevalence of Pseudoramibacter alactolyticus and Treponema denticola in primary infections

    Time frame: Beteen 1 and 6 months after samples collection.)

    Detection and prevalence rate of two specific bacterial species in untreated teeth with apical periodontitis using qPCR.

    Unit of Measure: Presence/absence and DNA copy number

  3. Reduction in P. alactolyticus and T. denticola load after treatment procedures

    Time frame: Beteen 1 and 6 months after samples collection.

    Quantification of bacterial load changes in P. alactolyticus and T. denticola following chemomechanical preparation and final irrigation.

    Unit of measure: Log reduction in species-specific DNA copy numbers

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Clinical Antibacterial Efficacy and Treatment Outcome After Implementing Various Root Canal Irrigating Procedures

Acronym: ENDOA

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
May 11, 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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