PeriodontitisNCT07755228
Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis
An observational study of Periodontitis and Periodontal Health, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Health
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2026to 4 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (single study visit)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start11 Jun 2026
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Can, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755228
- Sponsor's protocol ID
- 917
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the informed consent process did not include permission for public sharing of individual-level clinical and laboratory data. Aggregate and de-identified study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Gasdermin E and Granzyme B Levels in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT07755228
- Acronym / sponsor ID
- 917
- Conditions
- Periodontitis, Periodontal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Correlation Between Salivary Gasdermin E Levels and Clinical Periodontal Parameters
Time frame: At baseline (single study visit)
Correlation Between Salivary Granzyme B Levels and Clinical Periodontal Parameters
Time frame: At baseline (single study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the informed consent process did not include permission for public sharing of individual-level clinical and laboratory data. Aggregate and de-identified study findings will be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Periodontal Health, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Gasdermin E Concentration (time frame: At baseline (single study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.