- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879951
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
Status
Completed
Conditions
Intervention / Treatment
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
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Ankara, Turkey, 06490
- Gazi University Faculty of Dentistry
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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:
- Willingness to participate in the study.
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.
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.
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:
- 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.
- Individuals who are pregnant or breastfeeding.
- Individuals diagnosed with rheumatoid arthritis or lupus erythematosus.
- Individuals with a medical history of radiation or cancer therapy.
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).
- 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
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Participants are not assigned an intervention as part of the study.
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|
Obese individuals with periodontal healthy
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Participants are not assigned an intervention as part of the study.
|
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Normal-weight Individuals with Periodontitis
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Participants are not assigned an intervention as part of the study.
|
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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
Collaborators
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
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Cardiovascular Diseases
- Heart Diseases
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Heart Defects, Congenital
- Abnormalities, Multiple
- Bone Diseases, Developmental
- Periodontitis
- Marfan Syndrome
Other Study ID Numbers
- E-21071282-050.99-720599
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.