Adrenomedullin Upregulation in Apical Periodontitis

Periapical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297747
• Other study ID #: 472-10.06.2020
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: August 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Diagnostic Test:
• Apical periodontitis
Radiography of the patients were taken. Blood samples were collected from those patients.
• Chronic periodontitis
Radiography of the patients were taken. Blood samples were collected from those patient

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University, Faculty of Dentistry	Istanbul	Esenler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mid-Regional Pro Adrenomedullin levels	Biomarker levels of all patients were measured	through study completion, an average of 1 year