Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods
ENDOABG
2 other identifiers
interventional
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 28, 2025
CompletedFirst Posted
Study publicly available on registry
May 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedJune 3, 2025
June 1, 2025
5 months
April 28, 2025
June 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
0ne to six months
Secondary Outcomes (2)
Reduction in Specific Bacterial Species
one to six months
Clinical and Radiographic Healing Outcome
6 months and 12 months after root canal treatment
Other Outcomes (1)
Comparison of Antibacterial Effectiveness Between Interventions
Immediately post-treatment and at 12 months follow-up
Study Arms (3)
Final Irrigation with 2.5% Sodium Hypochlorite
OTHERRoot canals will be irrigated with 2.5% sodium hypochlorite as the final irrigation without activation.
Passive Ultrasonic Irrigation with NaOCl
OTHERRoot canals will be irrigated with 2.5% sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI).
XP-Endo Finisher activation with NaOCl
OTHERRoot canals will be irrigated with 2.5% sodium hypochlorite followed by mechanical activation using the XP-Endo Finisher file.
Interventions
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.
Activation of 2.5% sodium hypochlorite solution inside the root canal system using Passive Ultrasonic Irrigation (PUI) after chemomechanical preparation. Group B, sample (S3).
Mechanical activation of 2.5% sodium hypochlorite solution using the XP-Endo Finisher instrument following chemomechanical preparation.Group C, sample (S3).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National and Kapodistrian University of Athens
Athens, 11527, Greece
Related Publications (28)
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.
PMID: 14655819RESULTSiqueira 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.
PMID: 18928835RESULTLuciano 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.
RESULTWeber 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.
PMID: 14503827RESULTMohammadi 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.
PMID: 19961451RESULTRicucci 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.
PMID: 19345793RESULTSjogren 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.
PMID: 9477818RESULTSjogren 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.
PMID: 2084204RESULTPaixao 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.
PMID: 35430959RESULTMancini 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.
PMID: 24139274RESULTAlves 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.
PMID: 27215810RESULTMatoso 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.
PMID: 35442382RESULTPoly 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.
PMID: 35980742RESULTde 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.
PMID: 37867163RESULTAmaral 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.
PMID: 32653532RESULTBallal NV, Gandhi P, Shenoy PA, Dummer PMH. Evaluation of various irrigation activation systems to eliminate bacteria from the root canal system: A randomized controlled single blinded trial. J Dent. 2020 Aug;99:103412. doi: 10.1016/j.jdent.2020.103412. Epub 2020 Jun 22.
PMID: 32585261RESULTTzanetakis GN, Koletsi D, Tsakris A, Vrioni G. Prevalence of Fungi in Primary Endodontic Infections of a Greek-living Population Through Real-time Polymerase Chain Reaction and Matrix-assisted Laser Desorption/Ionization Time-of-flight Mass Spectrometry. J Endod. 2022 Feb;48(2):200-207. doi: 10.1016/j.joen.2021.11.003. Epub 2021 Nov 17.
PMID: 34800484RESULTCoaguila-Llerena H, Ordinola-Zapata R, Staley C, Dietz M, Chen R, Faria G. Multispecies biofilm removal by a multisonic irrigation system in mandibular molars. Int Endod J. 2022 Nov;55(11):1252-1261. doi: 10.1111/iej.13813. Epub 2022 Aug 30.
PMID: 35976101RESULTLima AR, Herrera DR, Francisco PA, Pereira AC, Lemos J, Abranches J, Gomes BPFA. Detection of Streptococcus mutans in symptomatic and asymptomatic infected root canals. Clin Oral Investig. 2021 Jun;25(6):3535-3542. doi: 10.1007/s00784-020-03676-9. Epub 2020 Nov 10.
PMID: 33170373RESULTSiqueira JF Jr, Rocas IN. Pseudoramibacter alactolyticus in primary endodontic infections. J Endod. 2003 Nov;29(11):735-8. doi: 10.1097/00004770-200311000-00012.
PMID: 14651280RESULTRosa TP, Signoretti FG, Montagner F, Gomes BP, Jacinto RC. Prevalence of Treponema spp. in endodontic retreatment-resistant periapical lesions. Braz Oral Res. 2015;29:S1806-83242015000100228. doi: 10.1590/1807-3107BOR-2015.vol29.0031. Epub 2015 Jan 27.
PMID: 25627883RESULTOrdinola-Zapata R, Costalonga M, Dietz M, Lima BP, Staley C. The root canal microbiome diversity and function. A whole-metagenome shotgun analysis. Int Endod J. 2024 Jul;57(7):872-884. doi: 10.1111/iej.13911. Epub 2023 Mar 29.
PMID: 36861850RESULTOrdinola-Zapata R, Costalonga M, Nixdorf D, Dietz M, Schuweiler D, Lima BP, Staley C. Taxonomic abundance in primary and secondary root canal infections. Int Endod J. 2023 Feb;56(2):278-288. doi: 10.1111/iej.13864. Epub 2022 Nov 22.
PMID: 36334085RESULTRocas 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.
PMID: 21238793RESULTOrstavik 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.
PMID: 3457698RESULTOrstavik D. Reliability of the periapical index scoring system. Scand J Dent Res. 1988 Apr;96(2):108-11.
PMID: 3162597RESULTKirkevang LL, Orstavik D, Wenzel A, Vaeth M. Prognostic value of the full-scale Periapical Index. Int Endod J. 2015 Nov;48(11):1051-8. doi: 10.1111/iej.12402. Epub 2014 Nov 24.
PMID: 25354086RESULTKirkevang LL, Orstavik D, Bahrami G, Wenzel A, Vaeth M. Prediction of periapical status and tooth extraction. Int Endod J. 2017 Jan;50(1):5-14. doi: 10.1111/iej.12581. Epub 2015 Dec 23.
PMID: 26580306RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giorge Tzanetakis, Dr (PhD)
National and Kapodistrian University of Athens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The operator performing the procedure is not blinded, but outcome assessors evaluating healing at follow-up could be blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 28, 2025
First Posted
May 6, 2025
Study Start
April 1, 2025
Primary Completion
September 1, 2025
Study Completion
October 31, 2025
Last Updated
June 3, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The individual participant data (IPD) and supporting documents will become available starting 6 months after the publication of the main study results. Data will be available for a minimum of 5 years thereafter.
- Access Criteria
- Researchers who provide a methodologically sound research proposal and agree to a data-sharing agreement will be eligible to access the data. Proposals will be reviewed by the study's advisory committee to ensure they are appropriate and ethical. Access will be granted for academic, non-commercial research purposes only. Data will be provided through a secure platform ensuring confidentiality and data protection.
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.