Inflammation-Related Endothelial Barrier Dysfunction in Patients With Apical Periodontitis

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.

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Key information

Conditions

Apical Periodontitis Healhty Inflammation Jaw Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology - University of Turin, Turin, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Apical lesions cure

Other

Treatment of apical lesions

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2025
First posted: Dec 18, 2025
Registry last updated: Dec 31, 2025

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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Completed