National and Kapodistrian University of Athens
Athens, 11527, Greece
NCT Number: NCT06949176
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.
This study is active but is not currently recruiting participants.
All sexes
Interventional
Not applicable
Athens, 11527, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Root canal procedures including access cavity preparation, chemomechanical instrumentation, irrigation with sodium hypoclorite (NaOCl), microbiological sampling and obturation with warm vertical compaction.
Other names: Endodontic thereapy.
Sodium Hypoclorite used as the primary irrigant in the root canal treatment at concentrations of 2.5% (Group A) and 5% (Group B).
Other names: NaOCl
Applied to the operating field and tooth as part of initial disinfection prior to cavity access.
Other names: H202
Used to inactivate sodium hypoclorite prior to sample collection.
Other names: Na2S2O3
Used to determine the working length of the root canal.
Other names: Morita apex locator.
Used for coronal flaring in root canal instrumentation.
Other names: Dentsply Maillefer rotary system.
Used for root canal instrumentation to full working length.
Other names: Nikinc and Coltene/Whaledent rotary systems.
Used to deliver irrigant into the root canal.
Other names: 27G Luer Lock needle.
Time frame: DAY 1: Immediately after chemomechanical preparation.
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.
Time frame: DAY 1: Immediately after final irrigation.
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.
Time frame: 1 year post tratment.
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.
Time frame: Beteen 1 and 6 months after samples collection.
Evaluation of "copious irrigation" effectiveness by measuring bacterial load after each of two equal 15 ml/5 min final irrigation stages.
Unit of Measure: Log reduction in total bacterial DNA copies per sample
Time frame: Beteen 1 and 6 months after samples collection.)
Detection and prevalence rate of two specific bacterial species in untreated teeth with apical periodontitis using qPCR.
Unit of Measure: Presence/absence and DNA copy number
Time frame: Beteen 1 and 6 months after samples collection.
Quantification of bacterial load changes in P. alactolyticus and T. denticola following chemomechanical preparation and final irrigation.
Unit of measure: Log reduction in species-specific DNA copy numbers
National and Kapodistrian University of Athens
Other
Clinical Antibacterial Efficacy and Treatment Outcome After Implementing Various Root Canal Irrigating Procedures
Acronym: ENDOA
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