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Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07755228
Enrollment
46
Registered
2026-08-10
Start date
2026-06-11
Completion date
2026-08-04
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Health, Periodontitis

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.

Interventions

None listed

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary Gasdermin E ConcentrationAt baseline (single study visit)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.
Salivary Granzyme B ConcentrationAt baseline (single study visit)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.

Secondary

MeasureTime frameDescription
Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal ParametersAt baseline (single study visit)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.
Correlation Between Salivary Granzyme B Levels and Clinical Periodontal ParametersAt baseline (single study visit)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026