NCT06949176

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

Clinical Antibacterial Efficacy and Treatment Outcome After Implementing Various Root Canal Irrigating Procedures

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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.

Conditions

• Apical Periodontitis
• Root Canal Infection

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	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).
DRUG	Hydrogen peroxide.	Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
DRUG	Sodium Sulfate.	Used to inactivate sodium hypoclorite prior to sample collection.
DEVICE	Root ZX mini apex locator (Morita).	Used to determine the working length of the root canal.
DEVICE	Protaper Gold rotary files (Dentslpy Maillefer).	Used for coronal flaring in root canal instrumentation.
DEVICE	Smarttrack and Hyflex totary files.	Used for root canal instrumentation to full working length.
DEVICE	Endo-Eze 27G irrigation needle (Ultradent).	Used to deliver irrigant into the root canal.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-12
• Completion: 2025-06-23
• First posted: 2025-04-29
• Last updated: 2025-05-11

Locations

1 site across 1 country: Greece