Adrenomedullin Upregulation in Apical Periodontitis

NCT ID: NCT05297747

Last Updated: 2023-08-29

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

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-10-30

Brief Summary

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The aim of the present study was to investigate the relationship between Apical periodontitis (AP) severity and inflammatory markers (IL-12, TNF-alpha), and Mid-Regional Pro Adrenomedullin (MR-proADM) in patients with AP. A total of 174 subjects were divided into three categories: AP group (n=82), Chronic periodontitis (CP) group (n=42), healthy control group (n=50). Blood samples were collected from all of the patients. Enzyme-linked immunosorbent assay was used to evaluate the samples.

Detailed Description

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Bone destruction in apical periodontitis (AP) depends on the microorganisms' efficiency to breach the host-epithelial barrier and various antimicrobial peptides. Mid-regional pro adrenomedullin (MR-proADM) is one such potent antimicrobial peptide, which plays a regulatory and stabilizing role among proinflammatory and anti-inflammatory cytokines. A broad range of cells and tissues produce MR-proADM such as adrenal medulla, kidney, lungs, and endothelial cells. MR-proADM was found to be present in circulation and in various biological fluids. It is reported to function both as a generalized hormone and locally affecting autocrine or paracrine mediator. Its plasma level is usually elevated in certain conditions such as heart failure, hypertensive situations, cerebro-vascular events, chronic kidney failure, diabetes mellitus, sepsis and periodontitis. Besides these, MR-proADM has drawn attention as it stimulates the proinflammatory cytokine IL-6 and suppresses cytokines, like TNF- α, for regulating inflammation, being a potent of inhibitor of apoptosis and stimulating angiogenesis in tumor cells. However, there is still a large information gap on MR-proADM. Despite all these effects, there is not enough information in the literature about the effect of MR-proADM on oral and dental health and its effectiveness in apical periodontitis. Whether AP can cause any alterations in the MR-proADM value is also unknown.

Therefore, the aim of this study is to investigate the relationship between AP severity and inflammatory markers (IL-12, TNF-alpha), and MR-proADM in patients with AP. In addition, the results will be compared with the results of healthy controls and patients with chronic periodontitis.

Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Apical periodontitis

Radiography of the patients in the apical periodontitis group was evaluated and blood samples were collected from those patients

Group Type EXPERIMENTAL

Apical periodontitis

Intervention Type DIAGNOSTIC_TEST

Radiography of the patients were taken. Blood samples were collected from those patients.

Chronic periodontitis

Radiography of the patients in the chronic periodontitis group was evaluated and blood samples were collected from those patients

Group Type EXPERIMENTAL

Chronic periodontitis

Intervention Type DIAGNOSTIC_TEST

Radiography of the patients were taken. Blood samples were collected from those patient

Control

Radiography of the participants in the healthy, control group was evaluated and blood samples were collected from those participants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Apical periodontitis

Radiography of the patients were taken. Blood samples were collected from those patients.

Intervention Type DIAGNOSTIC_TEST

Chronic periodontitis

Radiography of the patients were taken. Blood samples were collected from those patient

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Must be systemically healthy Patients with only apical periodontitis (for AP group) Patients with only chronic periodontitis (for CP group) Orally healthy patients

Exclusion Criteria

any local or systemic inflammatory disease connective tissue diseases like systemic lupus erythematosus (SLE) cardiovascular disease inflammatory and rheumatic disease diabetes rheumatoid arthritis, or Behcet's disease granulomatous diseases like sarcoidosis inflammatory intestinal diseases like ulcerative colitis and Crohn's autoimmune intestinal diseases like celiac thyroid diseases like Hashimoto and Graves patients who had taken antibiotics and/or anti-inflammatory drugs within the last 6 months those with pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seyda Ersahan, DDS, PhD

Principal Investigator, Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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472-10.06.2020

Identifier Type: -

Identifier Source: org_study_id

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