Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal
NCT ID: NCT06949176
Last Updated: 2025-05-11
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
44 participants
INTERVENTIONAL
2023-12-01
2025-06-23
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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).
Hydrogen peroxide.
Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
Sodium Sulfate.
Used to inactivate sodium hypoclorite prior to sample collection.
Experimental group B (5% NaOCl concentration)
Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl .
Root ZX mini apex locator (Morita).
Used to determine the working length of the root canal.
Protaper Gold rotary files (Dentslpy Maillefer).
Used for coronal flaring in root canal instrumentation.
Smarttrack and Hyflex totary files.
Used for root canal instrumentation to full working length.
Endo-Eze 27G irrigation needle (Ultradent).
Used to deliver irrigant into the root canal.
Interventions
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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.
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).
Hydrogen peroxide.
Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
Sodium Sulfate.
Used to inactivate sodium hypoclorite prior to sample collection.
Root ZX mini apex locator (Morita).
Used to determine the working length of the root canal.
Protaper Gold rotary files (Dentslpy Maillefer).
Used for coronal flaring in root canal instrumentation.
Smarttrack and Hyflex totary files.
Used for root canal instrumentation to full working length.
Endo-Eze 27G irrigation needle (Ultradent).
Used to deliver irrigant into the root canal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
Yes
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Giorgos Tzanetakis
Associate Professor, Department of Endodontics
Principal Investigators
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Giorgos Tzanetakis
Role: PRINCIPAL_INVESTIGATOR
National and Kapodistian University of Athens
Locations
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National and Kapodistrian University of Athens
Athens, , Greece
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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594/07.06.2023
Identifier Type: -
Identifier Source: org_study_id
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