Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

NCT07755228 | Completed

• 1 other identifier: 917
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Periodontal Health

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline (single study visit)

Secondary Outcomes (2)

• Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal Parameters

  At baseline (single study visit)

• Correlation Between Salivary Granzyme B Levels and Clinical Periodontal Parameters

  At baseline (single study visit)

Study Arms (2)

periodontitis

Individuals diagnosed with periodontitis based on clinical and radiographic periodontal examination. Saliva samples will be collected, and clinical periodontal measurements will be recorded.

periodontal healthy

Individuals with a clinically healthy periodontium. Saliva samples will be collected, and clinical periodontal measurements will be recorded.

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

The study population will consist of 40 systemically healthy adults aged 18 to 65 years who present to the Department of Periodontology at Istanbul Medipol University Faculty of Dentistry. Based on the 2017 AAP/EFP classification, 23 participants diagnosed with generalized Stage III Grade B periodontitis will constitute the periodontitis group, and 23 participants with an intact and clinically healthy periodontium will constitute the control group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof Dr.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: June 11, 2026
• Primary Completion: August 4, 2026
• Study Completion: August 4, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)