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Salivary and Serum Inflammatory Biomarkers in Diabetic Nephropathy by Periodontal Status

NCT07498894 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2026-03-27

No results posted yet for this study

Summary

Chronic inflammation underlies the bidirectional relationship between diabetes and periodontitis, a process that may be further exacerbated in the presence of diabetic nephropathy. While the roles of inflammatory cytokines such as TNF-α and IL-10 in both periodontal tissue destruction and diabetes-related microvascular complications remain unclear, NGAL is recognized as a biomarker for diabetic nephropathy but its association with periodontal disease is not well established. This study aimed to comparatively evaluate salivary and serum levels of NGAL, TNF-α, and IL-10 according to different periodontal conditions in individuals with newly diagnosed diabetes and those with diabetic nephropathy.

Conditions

  • Diabetic Nephropathy Type 2
  • Type 2 Diabetes
  • Periodontitis
  • Gingivitis
  • Periodontal Health

Interventions

DIAGNOSTIC_TEST

clinical periodontal measurements

Periodontal parameters such as PI, GI, BOP, PD, and CAL were measured using the Williams periodontal probe (Hu-Friedy, Chicago IL). PD and CAL were calculated at six surfaces per tooth, whereas PI and GI were measured at four surfaces per tooth. the periodontal status of patients was determined based on the Classification of Periodontal and peri-implant diseases and conditions stated in 2017 World Workshop

DIAGNOSTIC_TEST

serum samples

Peripheral blood samples were obtained from the antecubital vein. A total of 10 mL of venous blood was collected using separator vacutainer tubes and centrifuged at room temperature. The obtained serum was transferred into separate Eppendorf tubes. The tubes were sealed with parafilm, labeled, and stored at -80°C until the day of analysis. NGAL, TNF-alpha and IL-10 levels were analyzed with ELISA method

DIAGNOSTIC_TEST

saliva samples

Unstimulated whole saliva samples were collected using the passive drooling method into a sterile collection tube over a 10-minute period.The obtained saliva was transferred into separate Eppendorf tubes. The tubes were sealed with parafilm, labeled, and stored at -80°C until the day of analysis. NGAL, TNF-alpha and IL-10 levels were analyzed with ELISA method

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2025-12-12
Completion
2025-12-12

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498894 on ClinicalTrials.gov