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

NCT06949176 | Active Not Recruiting

• 1 other identifier: 594/07.06.2023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. . 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.

Conditions

Apical Periodontitis; Root Canal Infection

Keywords

apical periodontitis; copious irrigation; mechanical root canal preparation

Outcome Measures

Primary Outcomes (3)

• 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.

  DAY 1: Immediately after chemomechanical preparation.

• 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.

  DAY 1: Immediately after final irrigation.

• 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.

  1 year post tratment.

Secondary Outcomes (3)

• Additional bacterial load reduction between two sequential 15 ml irrigation periods

  Beteen 1 and 6 months after samples collection.

• Prevalence of Pseudoramibacter alactolyticus and Treponema denticola in primary infections

  Beteen 1 and 6 months after samples collection.)

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

  Beteen 1 and 6 months after samples collection.

Study Arms (2)

Experimental group A (2,5% NaOCl concentration)

EXPERIMENTAL

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.; Drug: Sodium Hypochlorite.; Drug: Hydrogen peroxide.; Drug: Sodium Sulfate.

Experimental group B (5% NaOCl concentration)

EXPERIMENTAL

Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl .

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).

Interventions

Root canal tratment using mecchanical and chemical preparation. PROCEDURE

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

Also known as: Endodontic thereapy.

Experimental group A (2,5% NaOCl concentration)

Sodium Hypochlorite. DRUG

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

Also known as: NaOCl

Experimental group A (2,5% NaOCl concentration)

Hydrogen peroxide. DRUG

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

Also known as: H202

Experimental group A (2,5% NaOCl concentration)

Sodium Sulfate. DRUG

Used to inactivate sodium hypoclorite prior to sample collection.

Also known as: Na2S2O3

Experimental group A (2,5% NaOCl concentration)

Root ZX mini apex locator (Morita). DEVICE

Used to determine the working length of the root canal.

Also known as: Morita apex locator.

Experimental group B (5% NaOCl concentration)

Protaper Gold rotary files (Dentslpy Maillefer). DEVICE

Used for coronal flaring in root canal instrumentation.

Also known as: Dentsply Maillefer rotary system.

Experimental group B (5% NaOCl concentration)

Smarttrack and Hyflex totary files. DEVICE

Used for root canal instrumentation to full working length.

Also known as: Nikinc and Coltene/Whaledent rotary systems.

Experimental group B (5% NaOCl concentration)

Endo-Eze 27G irrigation needle (Ultradent). DEVICE

Used to deliver irrigant into the root canal.

Also known as: 27G Luer Lock needle.

Experimental group B (5% NaOCl concentration)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 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.
• Teeth with periodontal pocket more than 4mm.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

National and Kapodistrian University of Athens

Athens, 11527, Greece

Location

Related Publications (15)

• 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.

  PMID: 21924201 RESULT

• 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.

  PMID: 25892512 RESULT

• 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.

  PMID: 32860137 RESULT

• 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.

  PMID: 18437843 RESULT

• 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.

  PMID: 30981431 RESULT

• 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.

  PMID: 24651335 RESULT

• 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.

  PMID: 3457698 RESULT

• 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.

  PMID: 22892736 RESULT

• 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.

  PMID: 21238793 RESULT

• 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.

  PMID: 21329812 RESULT

• 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.

  PMID: 22403423 RESULT

• 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.

  PMID: 27142579 RESULT

• 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.

  PMID: 28483164 RESULT

• 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.

  PMID: 15917679 RESULT

• 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.

  PMID: 14651280 RESULT

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Sodium Hypochlorite; Hydrogen Peroxide; sodium sulfate

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Peroxides; Anions; Ions; Electrolytes; Reactive Oxygen Species; Free Radicals; Organic Chemicals

Study Officials

• Giorgos Tzanetakis

  National and Kapodistian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Endodontics

Model Details: 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).

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 29, 2025
• Study Start: December 1, 2023
• Primary Completion: December 12, 2024
• Study Completion: June 23, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

GR (1)