Adrenomedullin Upregulation in Apical Periodontitis

NCT05297747 | Completed DMC

• 1 other identifier: 472-10.06.2020
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periapical Periodontitis

Keywords

Apical periodontitis, Chronic periodontitis, Mid regional proadrenomedullin, IL-12, TNF-α

Outcome Measures

Primary Outcomes (1)

• Mid-Regional Pro Adrenomedullin levels

  Biomarker levels of all patients were measured

  through study completion, an average of 1 year

Study Arms (3)

Apical periodontitis

EXPERIMENTAL

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

Diagnostic Test: Apical periodontitis

Chronic periodontitis

EXPERIMENTAL

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

Diagnostic Test: Chronic periodontitis

Control

NO INTERVENTION

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

Interventions

Apical periodontitis DIAGNOSTIC_TEST

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

Apical periodontitis

Chronic periodontitis DIAGNOSTIC_TEST

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

Chronic periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 28, 2022
• Study Start: June 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication
• Access Criteria: by email

Locations

TU (1)