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Completed

NCT Number: NCT04637659

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.

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Key information

Conditions

Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUS

Siena, 53100, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of E.Faecalis in the canal before the treatment for each group

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

    E.Faecalis prevalence in the canal before the treatment will be calculated for each group.

Secondary outcomes

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

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

    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

Other outcomes

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

    Time frame: 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.

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

  2. Ability of the endodontic treatment to remove E. Faecalis from the canal

    Time frame: 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

    Pre-post endodontic treatment comparison as to E. Faecalis presence in the canal will be carried out

  3. Correlation between the presence of E. Faecalis in the canal before the treatment and the presence of a radiographic lesion

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

    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)

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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