EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS

March 11, 2025 updated by: Buse Naz BÜYÜKAKÇALI ALTAY, Gazi University

Evaluation of Serum and Gingival Crevicular Fluid Asprosin Levels in Obese and Normal-Weight Patients with Periodontitis

Obesity and periodontitis are chronic inflammatory diseases that share common pathological mechanisms. Asprosin, a novel adipokine discovered in 2016, has not been extensively studied in relation to periodontal tissues. In our study, we investigate the levels of asprosin in both serum and gingival crevicular fluid of patients with obesity and those of normal weight who have periodontitis. Additionally, our research aims to clarify the pathophysiological mechanisms linking periodontitis and obesity by examining local and systemic levels of TNF-α, IL-6, and asprosin, alongside clinical periodontal parameters.

Study Overview

Study Type

Observational

Enrollment (Actual)

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

      • Ankara, Turkey, 06490
        • Gazi University Faculty of Dentistry

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients were recruited from the Periodontology Clinic at Gazi University Faculty of Dentistry between August 2023 and August 2024. All participants who met the inclusion criteria were included in the study. Before their participation, the study's purpose and methods were explained, and written informed consent was obtained.

Description

Inclusion Criteria:

  1. Willingness to participate in the study.
  2. Weight classification:

    • Obese individuals: Body mass index (BMI) of 30 kg/m² or higher.
    • Normal-weight individuals: BMI between 18.5 and 24.9 kg/m².
  3. Periodontal health status:

    • Bleeding on probing: less than 10%.
    • Periodontal pocket depth: less than 3 mm.
    • No sites showing attachment loss or alveolar bone loss on radiographs.
  4. For individuals with periodontitis:

    • At least two non-adjacent teeth must show signs of interdental attachment loss.
    • Periodontal pocket depth greater than 3 mm.

Exclusion Criteria:

  1. Individuals who have received periodontal therapy, any oral decontamination treatment, or antibiotics or steroids in the six months prior to the start of the study.
  2. Individuals who are pregnant or breastfeeding.
  3. Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.
  4. Individuals with a medical history of radiation or cancer therapy.
  5. Patients with diabetes, defined by:

    • Hemoglobin A1c (HbA1c) level greater than 6.5%.
    • Fasting blood glucose (FBG) greater than 126 mg/dL.
    • An abnormal oral glucose tolerance test (OGTT).
  6. Smokers.

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
Intervention / Treatment
Obese individiuals with periodontitis
Participants are not assigned an intervention as part of the study.
Obese individuals with periodontal healthy
Participants are not assigned an intervention as part of the study.
Normal-weight Individuals with Periodontitis
Participants are not assigned an intervention as part of the study.
Normal-weight Individuals with periodontal health
Participants are not assigned an intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biyomarker levels
Time Frame: 08.10.2023-08.10.2024
All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels
08.10.2023-08.10.2024

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Aysen Bodur, Professor, Gazi University Faculty of Dentistry Department of Periodontology

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)

August 8, 2023

Primary Completion (Actual)

August 10, 2024

Study Completion (Actual)

August 10, 2024

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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