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

Completed

• Conditions: Obesity; Periodontitis

• Registration Number: NCT06879951
• Lead Sponsor: Gazi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Primary Completion: 2024-08-10
• Study Completion: 2024-08-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biyomarker levels	08.10.2023-08.10.2024	All groups' GCF and serum levels of asprosin, TNF-α, and IL-6 levels

Trial Locations

Locations (1)

Gazi University Faculty of Dentistry; 🇹🇷 Ankara, Turkey