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Adrenomedullin Upregulation in Apical Periodontitis

Primary Purpose

Periapical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Apical periodontitis
Chronic periodontitis
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periapical Periodontitis focused on measuring Apical periodontitis, Chronic periodontitis, Mid regional proadrenomedullin, IL-12, TNF-α

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Apical periodontitis

Chronic periodontitis

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mid-Regional Pro Adrenomedullin levels
Biomarker levels of all patients were measured

Secondary Outcome Measures

Full Information

First Posted
March 9, 2022
Last Updated
August 26, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05297747
Brief Title
Adrenomedullin Upregulation in Apical Periodontitis
Official Title
Is Adrenomedullin Upregulation Due to Apical Periodontitis Independent of Periodontal Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
Apical periodontitis, Chronic periodontitis, Mid regional proadrenomedullin, IL-12, TNF-α

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apical periodontitis
Arm Type
Experimental
Arm Description
Radiography of the patients in the apical periodontitis group was evaluated and blood samples were collected from those patients
Arm Title
Chronic periodontitis
Arm Type
Experimental
Arm Description
Radiography of the patients in the chronic periodontitis group was evaluated and blood samples were collected from those patients
Arm Title
Control
Arm Type
No Intervention
Arm Description
Radiography of the participants in the healthy, control group was evaluated and blood samples were collected from those participants
Intervention Type
Diagnostic Test
Intervention Name(s)
Apical periodontitis
Intervention Description
Radiography of the patients were taken. Blood samples were collected from those patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
Chronic periodontitis
Intervention Description
Radiography of the patients were taken. Blood samples were collected from those patient
Primary Outcome Measure Information:
Title
Mid-Regional Pro Adrenomedullin levels
Description
Biomarker levels of all patients were measured
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol University, Faculty of Dentistry
City
Istanbul
State/Province
Esenler
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of the study, we are planning to share our data
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
by email

Learn more about this trial

Adrenomedullin Upregulation in Apical Periodontitis

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