Clinical Investigation of Chemomechanical Parameters for an Efficient Disinfection of the Root Canal
- Conditions
- Apical PeriodontitisRoot Canal Infection
- Interventions
- Procedure: Root canal tratment using mecchanical and chemical preparation.Device: Root ZX mini apex locator (Morita).Drug: Sodium Hypochlorite.Device: Protaper Gold rotary files (Dentslpy Maillefer).Drug: Hydrogen peroxide.Device: Smarttrack and Hyflex totary files.Drug: Sodium Sulfate.Device: Endo-Eze 27G irrigation needle (Ultradent).
- Registration Number
- NCT06949176
- Lead Sponsor
- National and Kapodistrian University of Athens
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group A (2,5% NaOCl concentration) Root canal tratment using mecchanical and chemical preparation. 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. Experimental group A (2,5% NaOCl concentration) Sodium Hypochlorite. 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. Experimental group A (2,5% NaOCl concentration) Sodium Sulfate. 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. Experimental group A (2,5% NaOCl concentration) Hydrogen peroxide. 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. Experimental group B (5% NaOCl concentration) Root ZX mini apex locator (Morita). Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl . Experimental group B (5% NaOCl concentration) Protaper Gold rotary files (Dentslpy Maillefer). Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl . Experimental group B (5% NaOCl concentration) Smarttrack and Hyflex totary files. Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl . Experimental group B (5% NaOCl concentration) Endo-Eze 27G irrigation needle (Ultradent). Group B will be formed by 22 patients and each teeth will receive 5 % NaOCl .
- Primary Outcome Measures
Name Time Method Reduction of total bacterial load after chemomechanical preparation using 2.5% and 5% NaOCl. 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.Clinical and radiographic treatment success. 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.
- Secondary Outcome Measures
Name Time Method Prevalence of Pseudoramibacter alactolyticus and Treponema denticola in primary infections 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 numberReduction in P. alactolyticus and T. denticola load after treatment procedures 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 numbersAdditional bacterial load reduction between two sequential 15 ml irrigation periods 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
Trial Locations
- Locations (1)
National and Kapodistrian University of Athens
🇬🇷Athens, Greece
National and Kapodistrian University of Athens🇬🇷Athens, Greece