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Inflammation-Related Endothelial Barrier Dysfunction in Patients With Apical Periodontitis

NCT ID: NCT07292363

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-09

Study Completion Date

2025-10-16

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Apical Periodontitis Healhty

Keywords

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Endodontics Apical Periodontitis Inflammation Endothelial barrier permeability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AP group

Healthy subjects with apical periodontitis between 25-55 years

Apical lesions cure

Intervention Type OTHER

Treatment of apical lesions

Control Group

Healthy subjects without apical periodontitis between 25-55 years

No interventions assigned to this group

Interventions

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Apical lesions cure

Treatment of apical lesions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damiano Pasqualini, DDS Ass Prof

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Department of Surgical Sciences - Dental School

Locations

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Department of Oncology - University of Turin

Turin, Italy, Italy

Site Status

Endodontics, Department of Surgical Sciences - Univeristy of Turin

Turin, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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0094485/II

Identifier Type: -

Identifier Source: org_study_id