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

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637659
• Other study ID #: EF001
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: October 10, 2020

Study information

• Verified date: November 2020
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 10, 2020
• Est. primary completion date: October 1, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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
Other	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
Primary	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	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