Clinical trial NCT04637659: E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation
Official title: E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Periodontitis
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of E.Faecalis in the canal before the treatment for each group
timeFrame: Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file
Secondary outcomes:
measure: Correlation between E.Faecalis presence in the canal before the treatment and the pulpal/periapical status
timeFrame: Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file
Other outcomes:
measure: Correlation between E. Faecalis presence in the canal before the treatment and its presence in saliva (pre-treatment)
timeFrame: 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.
measure: Ability of the endodontic treatment to remove E. Faecalis from the canal
timeFrame: 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
measure: Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion
timeFrame: Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References: