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

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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis
• Intervention / Treatment: Procedure: Root Canal Treatment

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • AOUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients in need of an endodontic treatment and meeting the inclusion/exclusion criteria will be eligible for the inclusion in the present study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy non-treated teeth; Healthy teeth being treated for restorative or prosthodontics reasons	Procedure: Root Canal Treatment; 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.
Healthy treated teeth; Teeth being retreated for restorative or prosthodontics reasons	Procedure: Root Canal Treatment; 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.
Irreversible pulpitis; Teeth being treated because of a poor pulpal status	Procedure: Root Canal Treatment; 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.
Post-treatment apical periodontitis; Teeth being retreated due to the presence of an apical lesion	Procedure: Root Canal Treatment; 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.
Necrosis; Teeth being treated because of pulpal necrosis	Procedure: Root Canal Treatment; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment)	Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment) will be calculated	Pre-treatment microbial sampling in saliva was carried out 1 day before rubber dam isolation. Pre-treatment microbial sampling in the canal was carried out once arrived at working length with a 10 K-file.
Ability of the endodontic treatment to remove E. Faecalis from the canal	Pre-post endodontic treatment comparison as to E. Faecalis presence in the canal will be carried out	Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file. Post treatment microbial sampling will be carried out at the end of the endodontic treatment after the final wash with EDTA and NaOCl
Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion	Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion (measured with the PAI score)	Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file

Collaborators and Investigators

• Sponsor: University of Siena

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 10, 2020

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (ACTUAL): November 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: EF001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No