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

NCT ID: NCT06879951

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2024-08-10

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.

Conditions

Periodontitis; Obesity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obese individiuals with periodontitis

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University Scientific Research Unit

UNKNOWN

Sponsor Role: collaborator

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Buse Naz BÜYÜKAKÇALI ALTAY

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aysen Bodur, Professor

Role: STUDY_DIRECTOR

Gazi University Faculty of Dentistry Department of Periodontology

Locations

Gazi University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-21071282-050.99-720599

Identifier Type: -

Identifier Source: org_study_id