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

NCT04637659 | Completed

• 1 other identifier: EF001
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between E.Faecalis presence in the canal before the treatment and the pulpal/periapical status

  Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file

Other Outcomes (3)

• Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment)

  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-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

  Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file

Study Arms (5)

Healthy non-treated teeth

Healthy teeth being treated for restorative or prosthodontics reasons

Procedure: Root Canal Treatment

Healthy treated teeth

Teeth being retreated for restorative or prosthodontics reasons

Procedure: Root Canal Treatment

Irreversible pulpitis

Teeth being treated because of a poor pulpal status

Procedure: Root Canal Treatment

Post-treatment apical periodontitis

Teeth being retreated due to the presence of an apical lesion

Procedure: Root Canal Treatment

Necrosis

Teeth being treated because of pulpal necrosis

Procedure: Root Canal Treatment

Interventions

Root Canal Treatment PROCEDURE

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 non-treated teeth; Healthy treated teeth; Irreversible pulpitis; Necrosis; Post-treatment apical periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• between the ages of 18 and 70;
• good systemic health.
• patients in need of an endodontic treatment/retreatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For each patient 4 samples will be taken with sterile paper cones: saliva sample before the endodontic treatment, canal sample pre and post treatment, negative control in the rubber dam.

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 20, 2020
• Study Start: June 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 10, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

IT (1)