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Completed

NCT Number: NCT07755228

Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, 34810, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Salivary Gasdermin E Concentration

    Time frame: At 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.

  2. Salivary Granzyme B Concentration

    Time frame: At 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 outcomes

  1. Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal Parameters

    Time frame: At 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.

  2. Correlation Between Salivary Granzyme B Levels and Clinical Periodontal Parameters

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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