Pulp NecrosisENDOABGNCT06959602

Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods

A study testing Final Irrigation with 2.5% Sodium Hypochlorite, Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite and XP-Endo Finisher Activation with Sodium Hypochlorite in people with Pulp Necrosis and Apical Periodontitis, run by National and Kapodistrian University of Athens at 1 site in Greece.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pulp Necrosis, Apical Periodontitis, Endodontic Treatment
What is being tested?: Final Irrigation with 2.5% Sodium Hypochlorite, Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite and XP-Endo Finisher Activation with Sodium Hypochlorite
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteGreece
Study dates: 1 Apr 2025to 31 Oct 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 18 to 80 years
All sexes
No healthy volunteers
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 radiographic evidence of 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 or teeth with the pulp chamber exposed to oral environment.
Teeth with periodontal pocket more than 4mm.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Greece1 site

National and Kapodistrian University of Athens
Athens, 11527

Other trials in Greece

About this study

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.

Read the detailed description

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.

Conditions: Pulp Necrosis, Apical Periodontitis, Endodontic Treatment
Being tested: Final Irrigation with 2.5% Sodium Hypochlorite, Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite, XP-Endo Finisher Activation with Sodium Hypochlorite
Keywords: Quantitative PCR (qPCR), Intracanal Bacteria, XP-Endo Finisher, Passive Ultrasonic Irrigation (PUI), Sodium Hypochlorite
Medical subject headings: Dental Pulp Necrosis, Periapical Periodontitis

What participants receive

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

Final Irrigation with 2.5% Sodium HypochloriteProcedure or surgery
Also called NaOCl 2.5%
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.
Passive Ultrasonic Irrigation (PUI) with Sodium HypochloriteProcedure or surgery
Also called PUI; Ultrasonic Activation; Passive Ultrasonic Irrigation
Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).
XP-Endo Finisher Activation with Sodium HypochloriteProcedure or surgery
Also called XP-Endo Finisher; XPF Activation
Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).

Study groups in NCT06959602
Study group	Role	What they receive
Final Irrigation with 2.5% Sodium Hypochlorite	Other	Root canals will be irrigated with 2.5% sodium hypochlorite as the final irrigation without activation. Receives: Procedure: Final Irrigation with 2.5% Sodium Hypochlorite
Passive Ultrasonic Irrigation with NaOCl	Other	Root canals will be irrigated with 2.5% sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI). Receives: Procedure: Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite
XP-Endo Finisher activation with NaOCl	Other	Root canals will be irrigated with 2.5% sodium hypochlorite followed by mechanical activation using the XP-Endo Finisher file. Receives: Procedure: XP-Endo Finisher Activation with Sodium Hypochlorite

What is being measured

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

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.
Measured: 0ne to six months

Secondary outcomes (2)

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.
Measured: 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.
Measured: 6 months and 12 months after root canal treatment

Timeline

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

1 Apr 202531 Oct 2025

First posted6 May 2025
Study start1 Apr 2025
Primary completion1 Sep 2025 (estimated)
Study completion31 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Pulp NecrosisStudies of the same condition, open and under way.
More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 66 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06959602
Sponsor's protocol ID: 691/18.02.2025
Other IDs: Giorge Tzanetakis
Acronym: ENDOABG
Status last verified: Jun 2025
First submitted: 28 Apr 2025
Last updated: 3 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Orstavik D. Root canal disinfection: a review of concepts and recent developments. Aust Endod J. 2003 Aug;29(2):70-4. doi: 10.1111/j.1747-4477.2003.tb00515.x.
PubMed 14655819
Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.
PubMed 18928835
Luciano Giardino, Marco Morra, Carlo Becce, Fernanda G. Pappen, Zahed Mohammadi, Flavio Palazzi,Comparative wettability of different sodium hypochlorite solutions,Giornale Italiano di Endodonzia.2012; 26(22):1121-4171 doi:org/10.1016/j.gien.2012.06.002.
Weber CD, McClanahan SB, Miller GA, Diener-West M, Johnson JD. The effect of passive ultrasonic activation of 2% chlorhexidine or 5.25% sodium hypochlorite irrigant on residual antimicrobial activity in root canals. J Endod. 2003 Sep;29(9):562-4. doi: 10.1097/00004770-200309000-00005.
PubMed 14503827
Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x.
PubMed 19961451
Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
PubMed 19345793
Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.
PubMed 9477818
Sjogren U, Hagglund B, Sundqvist G, Wing K. Factors affecting the long-term results of endodontic treatment. J Endod. 1990 Oct;16(10):498-504. doi: 10.1016/S0099-2399(07)80180-4.
PubMed 2084204
Paixao S, Rodrigues C, Grenho L, Fernandes MH. Efficacy of sonic and ultrasonic activation during endodontic treatment: a Meta-analysis of in vitro studies. Acta Odontol Scand. 2022 Nov;80(8):588-595. doi: 10.1080/00016357.2022.2061591. Epub 2022 Apr 17.
PubMed 35430959
Mancini M, Cerroni L, Iorio L, Armellin E, Conte G, Cianconi L. Smear layer removal and canal cleanliness using different irrigation systems (EndoActivator, EndoVac, and passive ultrasonic irrigation): field emission scanning electron microscopic evaluation in an in vitro study. J Endod. 2013 Nov;39(11):1456-60. doi: 10.1016/j.joen.2013.07.028. Epub 2013 Sep 6.
PubMed 24139274
Alves FR, Marceliano-Alves MF, Sousa JC, Silveira SB, Provenzano JC, Siqueira JF Jr. Removal of Root Canal Fillings in Curved Canals Using Either Reciprocating Single- or Rotary Multi-instrument Systems and a Supplementary Step with the XP-Endo Finisher. J Endod. 2016 Jul;42(7):1114-9. doi: 10.1016/j.joen.2016.04.007. Epub 2016 May 20.
PubMed 27215810
Matoso FB, Quintana RM, Jardine AP, Delai D, Fontanella VRC, Grazziotin-Soares R, Kopper PMP. XP Endo Finisher-R and PUI as supplementary methods to remove root filling materials from curved canals. Braz Oral Res. 2022 Apr 15;36:e053. doi: 10.1590/1807-3107bor-2022.vol36.0053. eCollection 2022.
PubMed 35442382
Poly A, Marques F, Lee J, Setzer FC, Karabucak B. XP-endo Finisher effectively reduces hard-tissue debris accumulated in root canals with isthmus after preparation with a reciprocating file system. Aust Endod J. 2023 Aug;49(2):279-286. doi: 10.1111/aej.12676. Epub 2022 Aug 18.
PubMed 35980742
de Jesus Oliveira LS, de Figueiredo FED, Dantas JA, Ribeiro MAG, Estrela C, Sousa-Neto MD, Faria-E-Silva AL. Impact XP-endo finisher on the 1-year follow-up success of posterior root canal treatments: a randomized clinical trial. Clin Oral Investig. 2023 Dec;27(12):7595-7603. doi: 10.1007/s00784-023-05349-9. Epub 2023 Oct 23.
PubMed 37867163
Amaral RR, Guimaraes Oliveira AG, Braga T, Reher P, de Macedo Farias L, Magalhaes PP, Ferreira PG, Ilma de Souza Cortes M. Quantitative Assessment of the Efficacy of Two Different Single-file Systems in Reducing the Bacterial load in Oval-Shaped Canals: A Clinical Study. J Endod. 2020 Sep;46(9):1228-1234. doi: 10.1016/j.joen.2020.06.007. Epub 2020 Jul 9.
PubMed 32653532

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
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All Pulp Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods
ClinicalTrials.gov ID: NCT06959602
Acronym / sponsor ID: ENDOABG / 691/18.02.2025
Conditions: Pulp Necrosis, Apical Periodontitis, Endodontic Treatment
Keywords: Quantitative PCR (qPCR), Intracanal Bacteria, XP-Endo Finisher, Passive Ultrasonic Irrigation (PUI), Sodium Hypochlorite
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 66 participants (estimated)
Lead sponsor: National and Kapodistrian University of AthensUniversity, hospital or other
Study start: 1 Apr 2025 (actual)
Primary completion: 1 Sep 2025 (estimated)
Study completion: 31 Oct 2025 (estimated)
First posted: 6 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Final Irrigation with 2.5% Sodium Hypochlorite	Other	Procedure: Final Irrigation with 2.5% Sodium HypochloriteRoot canals will be irrigated with 2.5% sodium hypochlorite as the final irrigation without activation.
Passive Ultrasonic Irrigation with NaOCl	Other	Procedure: Passive Ultrasonic Irrigation (PUI) with Sodium HypochloriteRoot canals will be irrigated with 2.5% sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI).
XP-Endo Finisher activation with NaOCl	Other	Procedure: XP-Endo Finisher Activation with Sodium HypochloriteRoot canals will be irrigated with 2.5% sodium hypochlorite followed by mechanical activation using the XP-Endo Finisher file.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Final Irrigation with 2.5% Sodium HypochloriteAlso: NaOCl 2.5%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.	Procedure or surgery	Final Irrigation with 2.5% Sodium Hypochlorite
Passive Ultrasonic Irrigation (PUI) with Sodium HypochloriteAlso: PUI; Ultrasonic Activation; Passive Ultrasonic IrrigationActivation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).	Procedure or surgery	Passive Ultrasonic Irrigation with NaOCl
XP-Endo Finisher Activation with Sodium HypochloriteAlso: XP-Endo Finisher; XPF ActivationMechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).	Procedure or surgery	XP-Endo Finisher activation with NaOCl

Primary outcome

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.

2 secondary outcomes

Reduction in Specific Bacterial Species
Time frame: one to six months
Clinical and Radiographic Healing Outcome
Time frame: 6 months and 12 months after root canal treatment

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Results publication: PubMed 14655819Orstavik D. Root canal disinfection: a review of concepts and recent developments. Aust Endod J. 2003 Aug;29(2):70-4. doi: 10.1111/j.1747-4477.2003.tb00515.x.
Results publication: PubMed 18928835Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod. 2008 Nov;34(11):1291-1301.e3. doi: 10.1016/j.joen.2008.07.028. Epub 2008 Sep 17.
Results publicationLuciano Giardino, Marco Morra, Carlo Becce, Fernanda G. Pappen, Zahed Mohammadi, Flavio Palazzi,Comparative wettability of different sodium hypochlorite solutions,Giornale Italiano di Endodonzia.2012; 26(22):1121-4171 doi:org/10.1016/j.gien.2012.06.002.
Results publication: PubMed 14503827Weber CD, McClanahan SB, Miller GA, Diener-West M, Johnson JD. The effect of passive ultrasonic activation of 2% chlorhexidine or 5.25% sodium hypochlorite irrigant on residual antimicrobial activity in root canals. J Endod. 2003 Sep;29(9):562-4. doi: 10.1097/00004770-200309000-00005.
Results publication: PubMed 19961451Mohammadi Z, Abbott PV. Antimicrobial substantivity of root canal irrigants and medicaments: a review. Aust Endod J. 2009 Dec;35(3):131-9. doi: 10.1111/j.1747-4477.2009.00164.x.
Results publication: PubMed 19345793Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod. 2009 Apr;35(4):493-502. doi: 10.1016/j.joen.2008.12.014.
Results publication: PubMed 9477818Sjogren U, Figdor D, Persson S, Sundqvist G. Influence of infection at the time of root filling on the outcome of endodontic treatment of teeth with apical periodontitis. Int Endod J. 1997 Sep;30(5):297-306. doi: 10.1046/j.1365-2591.1997.00092.x.
Results publication: PubMed 2084204Sjogren U, Hagglund B, Sundqvist G, Wing K. Factors affecting the long-term results of endodontic treatment. J Endod. 1990 Oct;16(10):498-504. doi: 10.1016/S0099-2399(07)80180-4.
Results publication: PubMed 35430959Paixao S, Rodrigues C, Grenho L, Fernandes MH. Efficacy of sonic and ultrasonic activation during endodontic treatment: a Meta-analysis of in vitro studies. Acta Odontol Scand. 2022 Nov;80(8):588-595. doi: 10.1080/00016357.2022.2061591. Epub 2022 Apr 17.
Results publication: PubMed 24139274Mancini M, Cerroni L, Iorio L, Armellin E, Conte G, Cianconi L. Smear layer removal and canal cleanliness using different irrigation systems (EndoActivator, EndoVac, and passive ultrasonic irrigation): field emission scanning electron microscopic evaluation in an in vitro study. J Endod. 2013 Nov;39(11):1456-60. doi: 10.1016/j.joen.2013.07.028. Epub 2013 Sep 6.
Results publication: PubMed 27215810Alves FR, Marceliano-Alves MF, Sousa JC, Silveira SB, Provenzano JC, Siqueira JF Jr. Removal of Root Canal Fillings in Curved Canals Using Either Reciprocating Single- or Rotary Multi-instrument Systems and a Supplementary Step with the XP-Endo Finisher. J Endod. 2016 Jul;42(7):1114-9. doi: 10.1016/j.joen.2016.04.007. Epub 2016 May 20.
Results publication: PubMed 35442382Matoso FB, Quintana RM, Jardine AP, Delai D, Fontanella VRC, Grazziotin-Soares R, Kopper PMP. XP Endo Finisher-R and PUI as supplementary methods to remove root filling materials from curved canals. Braz Oral Res. 2022 Apr 15;36:e053. doi: 10.1590/1807-3107bor-2022.vol36.0053. eCollection 2022.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Giorge Tzanetakis, Dr (PhD) principal investigator

National and Kapodistrian University of Athens

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: enrolling by invitation, as of the sponsor's last update on 3 Jun 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 in Total Intracanal Bacterial Load (time frame: 0ne to six months). 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 NCT06959602, which also lists 28 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 3 Jun 2025.