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CompletedNCT06879951Updated Mar 17, 2025

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

An observational study in Periodontitis and Obesity, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Periodontitis
  • Obesity

Keywords

  • Periodontitis
  • Obesity
  • Asprosin
  • Chronic Inflammatory Diseases
03

In context

Marfan Syndrome

71 studies on the registry are indexed under Marfan Syndrome; 16 are open to participants now.

This study's enrollment of 60 is below the median of 119 across 40 observational studies indexed under Marfan Syndrome.

Browse Marfan Syndrome studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Obese individiuals with periodontitis

    Other: Participants are not assigned an intervention as part of the study.

  • Obese individuals with periodontal healthy

    Other: Participants are not assigned an intervention as part of the study.

  • Normal-weight Individuals with Periodontitis

    Other: Participants are not assigned an intervention as part of the study.

  • Normal-weight Individuals with periodontal health

    Other: Participants are not assigned an intervention as part of the study.

Interventions

  • OtherParticipants are not assigned an intervention as part of the study.

    Participants are not assigned an intervention as part of the study.

06

What researchers measure

Primary outcomes

  1. Biyomarker levels

    All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels

    Time frame: 08.10.2023-08.10.2024

07

Study locations

1 site
  • Gazi University Faculty of Dentistry
    Ankara, 06490, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06879951
Lead sponsor
Gazi University
Collaborators
Gazi University Scientific Research Unit
Responsible party
Buse Naz BÜYÜKAKÇALI ALTAY (Research assistant, Gazi University) — Principal investigator
First posted
Mar 17, 2025
Start date
Aug 8, 2023
Primary completion
Aug 10, 2024
Completion
Aug 10, 2024
Last update
Mar 17, 2025

Study contacts

Aysen Bodur, Professor
study director · Gazi University Faculty of Dentistry Department of Periodontology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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