Investigation of Lipoxin A4, Annexin A1 and Interleukin-1 Beta Levels in Individuals With Periodontitis. (Lipoxin A4)

November 19, 2024 updated by: Eda Cetin Ozdemir

Investigation of Lipoxin A4, Annexin A1 and Interleukin-1 Beta Levels in Gingival Crevicular Fluid in Individuals With Stage 3 Grade A Periodontitis

Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Periodontitis is a chronic, multifactorial inflammatory disease characterized by microbial-mediated, host-mediated inflammation, resulting in periodontal attachment loss and eventual tooth loss. Given the high prevalence and systemic effects of periodontitis, research into the pathogenesis and treatment of periodontal disease is crucial to improving oral health and overall health outcomes.

In recent years, there has been great interest in determining the role of lipid mediators in pro- and anti-inflammatory events, which are of great importance in the pathogenesis of periodontitis. LIPOXIN A4 (LXA4), which serves as an inflammatory shutdown signal, is produced from arachidonic acid via interactions between individual lipoxygenases. Preclinical models have demonstrated the potential and efficacy of LXA4 in preventing the onset of periodontitis and treating periodontal disease by regenerating lost periodontium. LXA4 is produced by the dual oxygenation of arachidonic acid by 5-lipoxygenase and 12-lipoxygenase and mediates inflammatory suppression signals in vivo. LXA4 is biosynthesized by leukocytes, endothelial cells, and platelets via transcellular pathways and has potent inhibitory effects on various inflammatory mechanisms.

Annexins (ANXA) belong to the calcium (Ca+2) binding protein family that plays a role in inflammatory host defense. ANXA1, also known as lipocortin 1, is an anti-phospholipase protein that binds to cell membranes via a calcium-dependent pathway. ANXA1 inhibits the production of proinflammatory lipid mediators by inhibiting the activity of phospholipase A2. In addition, ANXA1 can modify many different steps and various cells involved in the inflammatory process. ANXA1 has long been classified as an anti-inflammatory protein due to its control over leukocyte-mediated immune responses. An ex vivo study has shown that the induction and translocation of ANXA1 protein to the cell membrane is stimulated by IL-6 . It has also been reported to be a critical negative regulator of proinflammatory mediators including IL-1, IL-6 and cyclooxygenase-2, while it has also been reported to stimulate the release of the anti-inflammatory cytokine IL-10 .

Since the researchers thought that Annexin A1, Lipoxin A4 and IL-1 Beta parameters, which have been found to be related to inflammatory conditions, may increase in periodontitis, a common inflammatory gum disease, we wanted to evaluate the changes in Annexin A1, Lipoxin A4 and IL-1 Beta levels in the Gingival Crevicular Fluid of participants with periodontitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Onikişubat
      • Kahramanmaraş, Onikişubat, Turkey, 46000
        • Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients applying to Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Periodontics

Description

Inclusion Criteria:

  • The patient must be a volunteer
  • He/she must be over 18 years old
  • He/she must not have any systemic disease

Exclusion Criteria:

  • Smoking, drinking alcohol
  • Being pregnant or breastfeeding
  • Not volunteering
  • Having had periodontal treatment in the last 6 months
  • Having used antibiotics or anti-inflammatory drugs in the last 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Healthy group
Other: Obtaining CGF from patients
Periodontal clinical parameters and Annexin and Lipoxin parameters in CGF will be compared between the test and control groups
Test group
Stage III Grade C Periodontitis
Other: Obtaining CGF from patients
Periodontal clinical parameters and Annexin and Lipoxin parameters in CGF will be compared between the test and control groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Annexin and Lipoxin parameters in CGF in periodontal disease
Time Frame: 6 mounth
We expect Annexin and Lipoxin parameters to decrease and IL-1b levels to increase in periodontal disease.
6 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eda Cetin Ozdemir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.05.2024-117
  • 2024/4-13 M (Other Grant/Funding Number: Scientific Research Projects Coordination Unit of Kahramanmaraş Sütçü İmam University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

ı don't want to share

Study Data/Documents

  1. Study Protocol
    Information identifier: Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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