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Completed

NCT Number: NCT05297747

Adrenomedullin Upregulation in Apical Periodontitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Apical periodontitis

Diagnostic Test

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

Chronic periodontitis

Diagnostic Test

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

Primary outcomes

  1. Mid-Regional Pro Adrenomedullin levels

    Time frame: through study completion, an average of 1 year

    Biomarker levels of all patients were measured

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Is Adrenomedullin Upregulation Due to Apical Periodontitis Independent of Periodontal Disease?

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 28, 2022
Registry last updated
Aug 29, 2023

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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