Salivary and Serum Inflammatory Biomarkers in Diabetic Nephropathy by Periodontal Status
1 other identifier
observational
126
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2025
CompletedFirst Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedMarch 27, 2026
March 1, 2026
1.5 years
March 23, 2026
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NGAL analysis
Mean NGAL levels (ng/ml) in serum and saliva
baseline
Secondary Outcomes (2)
TNF-alpha analysis
baseline
IL-10 analysis
baseline
Study Arms (6)
newly diagnosed type 2 diabetes and periodontal health
21 participants with newly diagnosed type 2 diabetes and periodontal health were recruited in group 1. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
newly diagnosed type 2 diabetes and gingivitis
20 participants with newly diagnosed type 2 diabetes and gingivitis were recruited in group 2. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
newly diagnosed type 2 diabetes and periodontitis
22 participants with newly diagnosed type 2 diabetes and gingivitis were recruited in group 3. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
diabetic nephropathy and periodontal health
21 participants with diabetic nephropathy and periodontal health were recruited in group 4. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
diabetic nephropathy and gingivitis
20 participants with diabetic nephropathy and gingivitis were recruited in group 5. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
diabetic nephropathy and periodontitis
22 participants with diabetic nephropathy and gingivitis were recruited in group 6. The clinical periodontal parameters taken are as follows: plaque index (PI), gingival index (GI), bleeding on brobing (BOP), probing depth (PD) and clinical attachment level (CAL). The present number of teeth in participants was recorded. Serum and saliva samples were collected for the analysis of biomarkers such as NGAL, IL-10, and TNF-α.
Interventions
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
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
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
Eligibility Criteria
Newly diagnosed type 2 diabetic subjects were recruited from patients diagnosed with type 2 diabetes for less than 5 years attending the outpatient clinic of the Department of Endocrinology, Pamukkale University Hospital and subsequently referred to the Department of Periodontology. Following periodontal examination, participants were diagnosed as periodontally healthy, gingivitis, or periodontitis, and were allocated to the corresponding study groups according to their periodontal status.
You may qualify if:
- Newly diagnosed diabetes: Diagnosed with type 2 diabetes mellitus for less than 5 years and the absence of any diabetic vascular complications
- Diabetic nephropathy: Urinary albumin-to-creatinine ratio \>30 mg/g
You may not qualify if:
- Having fewer than 15 natural teeth
- Pregnancy or lactation
- History of malignancy
- Use of systemic antibiotics or anti-inflammatory drugs within the 6 months prior to study enrollment
- Periodontal treatment within the previous 6 months
- Type 1 diabetes mellitus, gestational diabetes mellitus, or secondary diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University Faculty of Dentistry
Denizli, 20160, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 23, 2026
First Posted
March 27, 2026
Study Start
June 10, 2024
Primary Completion
December 12, 2025
Study Completion
December 12, 2025
Last Updated
March 27, 2026
Record last verified: 2026-03