Inflammation-Related Endothelial Barrier Dysfunction in Patients With Apical Periodontitis

December 23, 2025 updated by: University of Turin, Italy

Evaluation of Inflammation-Related Endothelial Barrier Dysfunction in Patients With Chronic Apical Periodontitis Before and After Endodontic Treatment

Inflammation is a common factor in chronic periodontitis and systemic diseases. However, to date, there is no scientific evidence supporting a causal effect of inflammation caused by apical periodontitis on endothelial barrier dysfunction.

A case-control study was designed to evaluate serum levels of endothelial barrier dysfunction factors in a sample of healthy patients aged 25 to 55, with or without apical periodontitis, before endodontic treatment and 6 and 12 months after treatment.

The aim of this study is to investigate the potential relationship between the presence of chronic endodontic lesions and inflammation-related alterations of the endothelial barrier that may compromise its integrity, as well as to determine whether endodontic treatment can reduce these factors, thereby preventing changes in endothelial permeability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Systemically healthy, informed, and consenting patients of both sexes under 55 years of age with a diagnosis of apical periodontitis who undergo endodontic treatment will be enrolled as cases and monitored at 6 and 12 months after treatment. Systemically healthy, informed, and consenting patients of both sexes under 55 years of age without apical periodontitis will be enrolled as control subjects.

The study has been designed to assess serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8), as well as the endothelial junctional proteins zonula occludens-1 (ZO-1), claudin-5, and vascular endothelial cadherin (VE-cadherin), using enzyme-linked immunosorbent assay (ELISA).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Turin, Italy, Italy, 10126
        • Department of Oncology - University of Turin
      • Turin, Italy, Italy, 10126
        • Endodontics, Department of Surgical Sciences - Univeristy of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Dental Hospital

Description

Inclusion Criteria:

  • 25-55 years
  • in general health
  • with or without endodontic disease

Exclusion Criteria:

  • under 25 years
  • over 55 years
  • subjects with systemic or oral diseases other than endodontic affections
  • patients who underwent other dental treatments in the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
AP group
Healthy subjects with apical periodontitis between 25-55 years
Other: Apical lesions cure
Treatment of apical lesions
Control Group
Healthy subjects without apical periodontitis between 25-55 years

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients before endodontic treatment
Time Frame: Baseline serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients before endodontic treatment - baseline. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
Baseline serum levels dosage of evaluated factors in control group and AP group.
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients after 6 months of endodontic treatment
Time Frame: 6 months post-treatment serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients- 6 months post-treatment. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
6 months post-treatment serum levels dosage of evaluated factors in control group and AP group.
Quantification of serum inflammatory cytokines (TNF-α, IL-1β, IL-6 and IL-8) and endothelial integrity factors (ZO-1, Claudin-5 and VE-cadherin) by ELISA assays in healthy subjects and patients after 12 months of endodontic treatment
Time Frame: Time Frame: 12 months post-treatment serum levels dosage of evaluated factors in control group and AP group.
Dosage of serum TNF-α, IL-1β, IL-6, IL-8 and ZO-1, Claudin-5 and VE-cadherin levels by ELISA assays measured as pg/ml of serum in healthy subjects and patients- 12 months post-treatment. Data relative to each evaluated serum protein will be aggregated as healthy (control group) versus pathological (AP group) individuals.
Time Frame: 12 months post-treatment serum levels dosage of evaluated factors in control group and AP group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turin, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Damiano Pasqualini, DDS Ass Prof, University of Turin, Department of Surgical Sciences - Dental School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0094485/II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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