Periodontal DiseasesNCT07497828
GCF and Saliva Levels of IL-36α in Periodontal Disease
A study testing Collection of fluid samples in people with Periodontal Diseases and Saliva, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Saliva, Gingival Crevicular Fluid
- What is being tested?
- Collection of fluid samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2023to 10 Jan 2025
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 20 teeth
- older than 18 years
Who cannot join
- any systemic disease
- pregnant or lactating
- history of radiotherapy or chemotherapy
- used antibiotics or any anti-inflammatory medication
- smokers
- had undergone periodontal treatment within the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IL-36α Levels in Saliva and Gingival Crevicular Fluid of the Patients With Periodontal Disease
Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with periodontitis, gingivitis and periodontally healthy individuals and to compare these levels with clinical parameters.
Read the detailed description
Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with periodontitis, gingivitis and periodontally healthy individuals and to compare these levels with clinical parameters.
Materials and Methods: A total of 80 systemically healthy, non-smokers aged between 25 and 55 including 20 periodontally healthy individuals, 20 individuals with gingivitis, 20 individuals with Stage III Grade B periodontitis, and 20 individuals with Stage III Grade C periodontitis were involved in our study. Clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP), were recorded. GCF and unstimulated saliva samples were collected from all participants. IL-36α levels were quantified using enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Periodontal Diseases, Saliva, Gingival Crevicular Fluid, Cytokine
- Being tested
- Collection of fluid samples
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of fluid samplesDiagnostic test
Collection of Gingival crevicular fluid and saliva from all patients at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Periodontally and systemically healthy individuals Receives: Diagnostic Test: Collection of fluid samples |
| Gingivitis | Other | Systemically healthy and patients with Gingivitis Receives: Diagnostic Test: Collection of fluid samples |
| Stage III Grade B Periodontitis | Other | systemically healthy and patients with Stage III Grade B periodontitis Receives: Diagnostic Test: Collection of fluid samples |
| Stage III Grade C Periodontitis | Other | systemically healthy and patients with Stage III Grade C periodontitis Receives: Diagnostic Test: Collection of fluid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-36α levels
IL-36α levels in the gingival crevicular fluid (GCF) and saliva of the all groups
Measured: Baseline
Secondary outcomes (5)
Plaque index (PI)
to measure plaque level in all groups
Measured: Baseline
Gingival index (GI)
to measure the level of gingival inflammation in all groups
Measured: Baseline
Probing pocket depth (PPD)
to measure the level of soft and hard tissue destructionin all groups
Measured: Baseline
Clinical attachment level (CAL)
to measure the attachment loss level in all groups
Measured: Baseline
Bleeding on probing (BOP)
to measure the severity of bleeding in all groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Dec 2023
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr. Figen ÖNGÖZ DEDE, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497828
- Sponsor's protocol ID
- 2023\314
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, sharing the IPD data is currently being considered.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-36α Levels in Saliva and Gingival Crevicular Fluid of the Patients With Periodontal Disease
- ClinicalTrials.gov ID
- NCT07497828
- Acronym / sponsor ID
- 2023\314
- Conditions
- Periodontal Diseases, Saliva, Gingival Crevicular Fluid, Cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 27 Mar 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.
Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with periodontitis, gingivitis and periodontally healthy individuals and to compare these levels with clinical parameters.
Detailed description
Interleukin-36 (IL-36), recently identified and members of the IL-1 family, have been reported to be important regulators of host defense against pathogens in the oral mucosa. The aim of this study was to investigate the levels of IL-36 alpha (α) in saliva and gingival crevicular fluid (GCF) of patients with periodontitis, gingivitis and periodontally healthy individuals and to compare these levels with clinical parameters.
Materials and Methods: A total of 80 systemically healthy, non-smokers aged between 25 and 55 including 20 periodontally healthy individuals, 20 individuals with gingivitis, 20 individuals with Stage III Grade B periodontitis, and 20 individuals with Stage III Grade C periodontitis were involved in our study. Clinical parameters, including plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing (BOP), were recorded. GCF and unstimulated saliva samples were collected from all participants. IL-36α levels were quantified using enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Diagnostic Test: Collection of fluid samplesPeriodontally and systemically healthy individuals |
| Gingivitis | Other | Diagnostic Test: Collection of fluid samplesSystemically healthy and patients with Gingivitis |
| Stage III Grade B Periodontitis | Other | Diagnostic Test: Collection of fluid samplessystemically healthy and patients with Stage III Grade B periodontitis |
| Stage III Grade C Periodontitis | Other | Diagnostic Test: Collection of fluid samplessystemically healthy and patients with Stage III Grade C periodontitis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- at least 20 teeth
- older than 18 years
Key exclusion criteria (6 listed)
- any systemic disease
- pregnant or lactating
- history of radiotherapy or chemotherapy
- used antibiotics or any anti-inflammatory medication
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of fluid samplesCollection of Gingival crevicular fluid and saliva from all patients at baseline. | Diagnostic test | Control group, Gingivitis, Stage III Grade B Periodontitis, Stage III Grade C Periodontitis |
Primary outcome
IL-36α levels
Time frame: Baseline
IL-36α levels in the gingival crevicular fluid (GCF) and saliva of the all groups
5 secondary outcomes
Plaque index (PI)
Time frame: Baseline
Gingival index (GI)
Time frame: Baseline
Probing pocket depth (PPD)
Time frame: Baseline
Clinical attachment level (CAL)
Time frame: Baseline
Bleeding on probing (BOP)
Time frame: Baseline
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 27 Mar 2026.
- Individual participant dataSharing planned: No. No, sharing the IPD data is currently being considered.
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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?
A study testing Collection of fluid samples in people with Periodontal Diseases and Saliva, run by Ordu 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 2 inclusion and 6 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 27 Mar 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?
IL-36α levels (time frame: Baseline). 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 27 Mar 2026.