Inflammation-Related Endothelial Barrier Dysfunction in Patients With Apical Periodontitis

NCT07292363 | Completed

• 1 other identifier: 0094485/II
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Apical Periodontitis; Healhty

Keywords

Endodontics; Apical Periodontitis; Inflammation; Endothelial barrier permeability

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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.

Study Arms (2)

AP group

Healthy subjects with apical periodontitis between 25-55 years

Other: Apical lesions cure

Control Group

Healthy subjects without apical periodontitis between 25-55 years

Interventions

Apical lesions cure OTHER

Treatment of apical lesions

AP group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Dental Hospital

You may qualify if:

• years
• in general health
• with or without endodontic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (2)

Department of Oncology - University of Turin

Turin, Italy, 10126, Italy

Location

Endodontics, Department of Surgical Sciences - Univeristy of Turin

Turin, Italy, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Sample

MeSH Terms

Conditions

Periapical Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Damiano Pasqualini, DDS Ass Prof

  University of Turin, Department of Surgical Sciences - Dental School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: February 9, 2021
• Primary Completion: April 30, 2022
• Study Completion: October 16, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

IT (2)