Clinical trial NCT06879951: EVALUATION of GINGIVAL CREVICULAR FLUID and SERUM ASPROSIN LEVELS in OBESE and NORMAL-WEIGHT INDIVIDUALS with PERIODONTITIS
Official title: Evaluation of Serum and Gingival Crevicular Fluid Asprosin Levels in Obese and Normal-Weight Patients with Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Obesity
Keywords: Periodontitis
Obesity
Asprosin
Chronic Inflammatory Diseases
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Gazi University Scientific Research Unit
First posted: 2025-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biyomarker levels
timeFrame: 08.10.2023-08.10.2024
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry
Study officials:
affiliation: Gazi University Faculty of Dentistry Department of Periodontology
name: Aysen Bodur, Professor
role: STUDY_DIRECTOR
References: