Apical PeriodontitisNCT04637659
E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation
An observational study of Apical Periodontitis, run by University of Siena at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Apical Periodontitis
- What is being tested?
- Root Canal Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- between the ages of 18 and 70;
- good systemic health.
- patients in need of an endodontic treatment/retreatment
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Root Canal Treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy non-treated teeth | Healthy teeth being treated for restorative or prosthodontics reasons Receives: Procedure: Root Canal Treatment | |
| Healthy treated teeth | Teeth being retreated for restorative or prosthodontics reasons Receives: Procedure: Root Canal Treatment | |
| Irreversible pulpitis | Teeth being treated because of a poor pulpal status Receives: Procedure: Root Canal Treatment | |
| Post-treatment apical periodontitis | Teeth being retreated due to the presence of an apical lesion Receives: Procedure: Root Canal Treatment | |
| Necrosis | Teeth being treated because of pulpal necrosis Receives: Procedure: Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: Pre-treatment microbial sampling in the canal was carried out 1 day once arrived at working length with a 10 K-file
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Jun 2019
- Primary completion1 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637659
- Sponsor's protocol ID
- EF001
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation
- ClinicalTrials.gov ID
- NCT04637659
- Acronym / sponsor ID
- EF001
- Conditions
- Apical Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy non-treated teeth | – | Procedure: Root Canal TreatmentHealthy teeth being treated for restorative or prosthodontics reasons |
| Healthy treated teeth | – | Procedure: Root Canal TreatmentTeeth being retreated for restorative or prosthodontics reasons |
| Irreversible pulpitis | – | Procedure: Root Canal TreatmentTeeth being treated because of a poor pulpal status |
| Post-treatment apical periodontitis | – | Procedure: Root Canal TreatmentTeeth being retreated due to the presence of an apical lesion |
| Necrosis | – | Procedure: Root Canal TreatmentTeeth being treated because of pulpal necrosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- between the ages of 18 and 70;
- good systemic health.
- patients in need of an endodontic treatment/retreatment
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root Canal TreatmentChemo-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. | Procedure or surgery | Healthy non-treated teeth, Healthy treated teeth, Irreversible pulpitis, Necrosis, Post-treatment apical periodontitis |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Apical Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apical Periodontitis, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.