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

NCT06879951 | Completed

• 1 other identifier: E-21071282-050.99-720599
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Periodontitis; Obesity; Asprosin; Chronic Inflammatory Diseases

Outcome Measures

Primary Outcomes (1)

• Biyomarker levels

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

  08.10.2023-08.10.2024

Study Arms (4)

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

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

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

Normal-weight Individuals with Periodontitis; Normal-weight Individuals with periodontal health; Obese individiuals with periodontitis; Obese individuals with periodontal healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead
• Gazi University Scientific Research Unit: collaborator

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Obesity; Arachnodactyly

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aysen Bodur, Professor

  Gazi University Faculty of Dentistry Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: August 8, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)