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

May 6, 2025 updated by: Giorgos Tzanetakis, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527
        • National and Kapodistrian University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group A (2,5% NaOCl concentration)
Group A will be formed by 22 patients and each teeth will receive 2,5% NaOCl . Working length (WL) will be established according to apex locator (Root ZX mini, Morita). Chemomechanical preparation will be completed in the same appointment.
Procedure: Root canal tratment using mecchanical and chemical preparation.
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.
Drug: Sodium Hypochlorite.
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
Drug: Hydrogen peroxide.
Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
Other Names:
  • H202
Drug: Sodium Sulfate.
Used to inactivate sodium hypoclorite prior to sample collection.
Other Names:
  • Na2S2O3
Experimental: Experimental group B (5% NaOCl concentration)
Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl .
Device: Root ZX mini apex locator (Morita).
Used to determine the working length of the root canal.
Other Names:
  • Morita apex locator.
Device: Protaper Gold rotary files (Dentslpy Maillefer).
Used for coronal flaring in root canal instrumentation.
Other Names:
  • Dentsply Maillefer rotary system.
Device: Smarttrack and Hyflex totary files.
Used for root canal instrumentation to full working length.
Other Names:
  • Nikinc and Coltene/Whaledent rotary systems.
Device: Endo-Eze 27G irrigation needle (Ultradent).
Used to deliver irrigant into the root canal.
Other Names:
  • 27G Luer Lock needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
DAY 1: Immediately after chemomechanical preparation.
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.
DAY 1: Immediately after final irrigation.
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.
1 year post tratment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Beteen 1 and 6 months after samples collection.
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
Beteen 1 and 6 months after samples collection.)
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
Beteen 1 and 6 months after samples collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Giorgos Tzanetakis, National and Kapodistian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

December 12, 2024

Study Completion (Estimated)

June 23, 2025

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 594/07.06.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data that support the findings of the study will be available from the corresponding author upon reasonable request

IPD Sharing Time Frame

Data requests will be submitted starting 9 months after article publication and the data will be made accessible up to 24 months. Extensions will be considered.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified investigators whose proposed research has received IRB approval. Data will be available via a data depository following execution of data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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