Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

Medipol University46 enrolled

Overview

This observational study aims to compare salivary Gasdermin E and Granzyme B levels between individuals with periodontitis and periodontally healthy individuals. It will also evaluate the relationships between these biomarkers and clinical periodontal measurements. Saliva samples and periodontal clinical measurements will be collected from all participants. No treatment or experimental intervention will be administered as part of the study. The findings may contribute to a better understanding of the inflammatory mechanisms associated with periodontitis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Periodontitis Periodontal Health

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals aged 18 to 65 years * Presence of at least 20 natural teeth, excluding third molars * Being systemically healthy * Provision of written informed consent * For the periodontitis group, diagnosis of generalized Stage III Grade B periodontitis according to the 2017 AAP/EFP classification * Clinical attachment loss of at least 2 mm at two or more non-adjacent teeth for the periodontitis group * Interdental clinical attachment loss of at least 5 mm and periodontitis-related loss of no more than four teeth for Stage III periodontitis * A radiographic bone loss-to-age ratio between 0.25 and 1.00 for Grade B periodontitis * For the healthy control group, an intact periodontium, probing depth of 3 mm or less, and bleeding on probing at less than 10% of sites Exclusion Criteria: * Use of antibiotics, antimicrobial agents, nonsteroidal anti-inflammatory drugs, steroids, immunosuppressants, beta-blockers, calcium channel blockers, anticoagulants, or hormonal contraceptives within the previous 3 months * Periodontal treatment within the previous 6 months * Surgical periodontal treatment within the previous 12 months * Current smoking * Pregnancy or breastfeeding * Presence of any neurological, autoimmune, metabolic, inflammatory, or other systemic condition that could affect the immune response * Use of an orthodontic appliance

Locations (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Salivary Gasdermin E Concentration

Gasdermin E concentration in unstimulated whole saliva samples will be measured using an enzyme-linked immunosorbent assay (ELISA) and compared between the periodontitis and periodontally healthy groups.

Time frame: At baseline (single study visit)

Salivary Granzyme B Concentration

Granzyme B concentration in unstimulated whole saliva samples will be measured using an enzyme-linked immunosorbent assay (ELISA) and compared between the periodontitis and periodontally healthy groups.

Time frame: At baseline (single study visit)

Secondary Outcomes

Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal Parameters

The correlations between salivary Gasdermin E levels and full-mouth plaque index (PI), bleeding on probing (BOP; percentage of sites), mean probing pocket depth (PPD; mm), and mean clinical attachment loss (CAL; mm) will be evaluated.

Time frame: At baseline (single study visit)

Correlation Between Salivary Granzyme B Levels and Clinical Periodontal Parameters

The correlations between salivary Granzyme B levels and full-mouth plaque index (PI), bleeding on probing (BOP; percentage of sites), mean probing pocket depth (PPD; mm), and mean clinical attachment loss (CAL; mm) will be evaluated.

Time frame: At baseline (single study visit)

Data from ClinicalTrials.gov

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