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Apical PeriodontitisENDOANCT06949176

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

A study testing Root canal tratment using mecchanical and chemical preparation., Sodium Hypochlorite. and Hydrogen peroxide. in people with Apical Periodontitis and Root Canal Infection, run by National and Kapodistrian University of Athens at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. . Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Apical Periodontitis, Root Canal Infection
What is being tested?
Root canal tratment using mecchanical and chemical preparation., Sodium Hypochlorite. and Hydrogen peroxide.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteGreece
Study dates
1 Dec 2023to 23 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • National and Kapodistrian University of Athens

    Athens, 11527

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Being tested
Root canal tratment using mecchanical and chemical preparation., Sodium Hypochlorite., Hydrogen peroxide., Sodium Sulfate., Root ZX mini apex locator (Morita).
Keywords
apical periodontitis, copious irrigation, mechanical root canal preparation
Medical subject headings
Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Root canal tratment using mecchanical and chemical preparation.Procedure or surgery

    Also called Endodontic thereapy.

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

  • Sodium Hypochlorite.Drug

    Also called NaOCl

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

  • Hydrogen peroxide.Drug

    Also called H202

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

  • Sodium Sulfate.Drug

    Also called Na2S2O3

    Used to inactivate sodium hypoclorite prior to sample collection.

  • Root ZX mini apex locator (Morita).Device

    Also called Morita apex locator.

    Used to determine the working length of the root canal.

  • Protaper Gold rotary files (Dentslpy Maillefer).Device

    Also called Dentsply Maillefer rotary system.

    Used for coronal flaring in root canal instrumentation.

  • Smarttrack and Hyflex totary files.Device

    Also called Nikinc and Coltene/Whaledent rotary systems.

    Used for root canal instrumentation to full working length.

  • Endo-Eze 27G irrigation needle (Ultradent).Device

    Also called 27G Luer Lock needle.

    Used to deliver irrigant into the root canal.

Study groups in NCT06949176
Study groupRoleWhat they receive
Experimental group A (2,5% NaOCl concentration)ExperimentalGroup 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.
Receives: Procedure: Root canal tratment using mecchanical and chemical preparation.; Drug: Sodium Hypochlorite.; Drug: Hydrogen peroxide.; Drug: Sodium Sulfate.
Experimental group B (5% NaOCl concentration)ExperimentalGroup B will be formed by 22 patients and each teeth will receive 5 % NaOCl .
Receives: Device: Root ZX mini apex locator (Morita).; Device: Protaper Gold rotary files (Dentslpy Maillefer).; Device: Smarttrack and Hyflex totary files.; Device: Endo-Eze 27G irrigation needle (Ultradent).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: DAY 1: Immediately after chemomechanical preparation.

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

    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.

    Measured: DAY 1: Immediately after final irrigation.

  3. Clinical and radiographic treatment success.

    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.

    Measured: 1 year post tratment.

Secondary outcomes (3)

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

    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

    Measured: Beteen 1 and 6 months after samples collection.

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

    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

    Measured: Beteen 1 and 6 months after samples collection.)

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

    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

    Measured: Beteen 1 and 6 months after samples collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start1 Dec 2023
  3. Primary completion12 Dec 2024
  4. Study completion23 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The present research will be designed as two-arm, parallel, randomized clinical study. The randomization of the teeth for sampling will be performed through the use of a special software . All the treatment and sampling procedures will be carried out by the same investigator (PhD candidate Dr. Agapi Zervaki).
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949176
Sponsor's protocol ID
594/07.06.2023
Acronym
ENDOA
Status last verified
May 2025
First submitted
1 Apr 2025
Last updated
11 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of the study will be available from the corresponding author upon reasonable request

Publications

  • Alves FR, Almeida BM, Neves MA, Rocas IN, Siqueira JF Jr. Time-dependent antibacterial effects of the self-adjusting file used with two sodium hypochlorite concentrations. J Endod. 2011 Oct;37(10):1451-5. doi: 10.1016/j.joen.2011.06.001. Epub 2011 Jul 27.

    PubMed 21924201

  • Antunes HS, Rocas IN, Alves FR, Siqueira JF Jr. Total and Specific Bacterial Levels in the Apical Root Canal System of Teeth with Post-treatment Apical Periodontitis. J Endod. 2015 Jul;41(7):1037-42. doi: 10.1016/j.joen.2015.03.008. Epub 2015 Apr 17.

    PubMed 25892512

  • Barbosa-Ribeiro M, Arruda-Vasconcelos R, Louzada LM, Dos Santos DG, Andreote FD, Gomes BPFA. Microbiological analysis of endodontically treated teeth with apical periodontitis before and after endodontic retreatment. Clin Oral Investig. 2021 Apr;25(4):2017-2027. doi: 10.1007/s00784-020-03510-2. Epub 2020 Aug 28.

    PubMed 32860137

  • Cavrini F, Pirani C, Foschi F, Montebugnoli L, Sambri V, Prati C. Detection of Treponema denticola in root canal systems in primary and secondary endodontic infections. A correlation with clinical symptoms. New Microbiol. 2008 Jan;31(1):67-73.

    PubMed 18437843

  • Gazzaneo I, Vieira GCS, Perez AR, Alves FRF, Goncalves LS, Mdala I, Siqueira JF Jr, Rocas IN. Root Canal Disinfection by Single- and Multiple-instrument Systems: Effects of Sodium Hypochlorite Volume, Concentration, and Retention Time. J Endod. 2019 Jun;45(6):736-741. doi: 10.1016/j.joen.2019.02.017. Epub 2019 Apr 10.

    PubMed 30981431

  • Haapasalo M, Shen Y, Wang Z, Gao Y. Irrigation in endodontics. Br Dent J. 2014 Mar;216(6):299-303. doi: 10.1038/sj.bdj.2014.204.

    PubMed 24651335

  • Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

    PubMed 3457698

  • Paiva SS, Siqueira JF Jr, Rocas IN, Carmo FL, Ferreira DC, Curvelo JA, Soares RM, Rosado AS. Supplementing the antimicrobial effects of chemomechanical debridement with either passive ultrasonic irrigation or a final rinse with chlorhexidine: a clinical study. J Endod. 2012 Sep;38(9):1202-6. doi: 10.1016/j.joen.2012.06.023. Epub 2012 Jul 25.

    PubMed 22892736

  • Rocas IN, Siqueira JF Jr. Comparison of the in vivo antimicrobial effectiveness of sodium hypochlorite and chlorhexidine used as root canal irrigants: a molecular microbiology study. J Endod. 2011 Feb;37(2):143-50. doi: 10.1016/j.joen.2010.11.006.

    PubMed 21238793

  • Rocas IN, Siqueira JF Jr. In vivo antimicrobial effects of endodontic treatment procedures as assessed by molecular microbiologic techniques. J Endod. 2011 Mar;37(3):304-10. doi: 10.1016/j.joen.2010.11.003. Epub 2010 Dec 30.

    PubMed 21329812

  • Rocas IN, Siqueira JF Jr. Characterization of microbiota of root canal-treated teeth with posttreatment disease. J Clin Microbiol. 2012 May;50(5):1721-4. doi: 10.1128/JCM.00531-12. Epub 2012 Mar 7.

    PubMed 22403423

  • Rocas IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. doi: 10.1016/j.joen.2016.03.019. Epub 2016 Apr 30.

    PubMed 27142579

  • Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Orstavik D, Rocas IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5.

    PubMed 28483164

  • Siqueira JF Jr, Rocas IN. Exploiting molecular methods to explore endodontic infections: Part 1--current molecular technologies for microbiological diagnosis. J Endod. 2005 Jun;31(6):411-23. doi: 10.1097/01.don.0000157989.44949.26.

    PubMed 15917679

  • Siqueira JF Jr, Rocas IN. Pseudoramibacter alactolyticus in primary endodontic infections. J Endod. 2003 Nov;29(11):735-8. doi: 10.1097/00004770-200311000-00012.

    PubMed 14651280

Questions about this trial

What is this clinical trial studying?

A study testing Root canal tratment using mecchanical and chemical preparation., Sodium Hypochlorite. and Hydrogen peroxide. in people with Apical Periodontitis and Root Canal Infection, run by National and Kapodistrian University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl. (time frame: DAY 1: Immediately after chemomechanical preparation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06949176, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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