E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation

Study Overview
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Brief Summary
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Post-treatment apical periodontitis is a fairly prevalent condition frequently caused by a persistent endodontic infection due to failure of the endodontic treatment. Microbial species in treated or untreated root canals were found to be different, with the former being less diverse and mainly characterized by Gram positive, facultative anaerobes bacteria than the latter. Enterococcus faecalis is the most frequently detected species in root-filled teeth in many studies (Zhang et al., 2015). In fact, E. Faecalis retains many virulence factors allowing adhesion to host cells and extracellular matrix, tissue invasion and damage through toxins release, as well as the ability to survive even in harsh environmental conditions. Further studies are needed to clarify E. faecalis prevalence among the different forms of pulpal and periapical lesions as well as its correlation with clinical symptoms.

Official Title
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E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation

Conditions
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Apical Periodontitis

Intervention / Treatment
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* Procedure: Root Canal Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: between the ages of 18 and 70; good systemic health. patients in need of an endodontic treatment/retreatment Exclusion criteria: taking antibiotic therapy in the previous 3 months; presence of communication between the canal system and the oral cavity; teeth that are not perfectly isolated; teeth with probing depth >4 mm with positive BOP.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy non-treated teeth<br>Healthy teeth being treated for restorative or prosthodontics reasons | Procedure: Root Canal Treatment<br>* Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.<br>|
| Healthy treated teeth<br>Teeth being retreated for restorative or prosthodontics reasons | Procedure: Root Canal Treatment<br>* Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.<br>|
| Irreversible pulpitis<br>Teeth being treated because of a poor pulpal status | Procedure: Root Canal Treatment<br>* Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.<br>|
| Post-treatment apical periodontitis<br>Teeth being retreated due to the presence of an apical lesion | Procedure: Root Canal Treatment<br>* Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.<br>|
| Necrosis<br>Teeth being treated because of pulpal necrosis | Procedure: Root Canal Treatment<br>* Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of E.Faecalis in the canal before the treatment for each group | E.Faecalis prevalence in the canal before the treatment will be calculated for each group. | Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between E.Faecalis presence in the canal before the treatment and the pulpal/periapical status | Correlation between E. faecalis presence in the canal before the treatment and the pulpal/periapical status for each group will be calculated through measures of association | Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file |