PeriodontitisNCT07312552
Association of Periodontal Status and Smoking With Salivary Inflammasome Markers
An observational study of Periodontitis and Periodontal Disease, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like… 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 Disease, Periodontal Health
- What is being tested?
- Periodontal examinations and Collection of saliva samples
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2025to Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 will consist of four groups: Group 1: healthy individuals (control (C)), Group 2: smokers with healthy periodontium (S-C), Group 3: nonsmokers with Stage III/IV periodontitis (P), Group 4: smokers with Stage III/IV periodontitis (S-P)
Who may be able to join
- systemically healthy,
- clinical diagnosis of periodontitis,
- clinical diagnosis of periodontal health
Who cannot join
- history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
- nonsurgical periodontal treatment (previous 6 months);
- surgical periodontal treatment (previous 12 months);
- presence of <20 teeth;
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
- diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, or excessive alcohol consumption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University, Faculty of Dentistry
Istanbul
About this study
Official title: The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study
The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.
Read the detailed description
The aim of this study was to determine the periodontal status and smoking status of the participants, to obtain clinical periodontal records and to explain their relationship with salivary NLRP-3 NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10 levels.
The participants included in the study will be divided into four groups: smokers with periodontal disease, non-smokers with periodontal disease, smokers without periodontal disease, and non-smokers without periodontal disease. Systemic and dental anamnesis of the participants will be taken, smoking habits will be evaluated, medical records and current diagnoses will be examined, intraoral examinations will be performed and periodontal records will be taken. The periodontal status of the participants will be diagnosed according to the 'Classification of Periodontal and Peri-implant Diseases and Conditions' accepted at the 2017 World Workshop, supported by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).
Saliva samples will be collected before clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analyzed. Salivary NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL1β, and IL-10 levels will be measured using an enzyme-linked immunosorbent assay (ELISA) method.
- Conditions
- Periodontitis, Periodontal Disease, Periodontal Health, Smoking, Inflammasomes
- Being tested
- Periodontal examinations, Collection of saliva samples
- Medical subject headings
- Periodontitis, Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examinationsDiagnostic test
With periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded.
Collection of saliva samplesDiagnostic test
Levels of salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β), and interleukin-10 (IL-10) will be determined using an enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (C) | Healthy individuals (control (C)) Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples | |
| Group 2 (S-C) | Smokers with healthy periodontium (S-C) Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples | |
| Group 3 (P) | Nonsmokers with Stage III/IV periodontitis (P) Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples | |
| Group 4 (S-P) | Smokers with Stage III/IV periodontitis (S-P) Receives: Diagnostic Test: Periodontal examinations; Diagnostic Test: Collection of saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (mm)
Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time.
Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth.
In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ.
In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.
Measured: Baseline
Probing pocket depth
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Measured: Baseline
Bleeding on probing
The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).
Measured: Baseline
Secondary outcomes (8)
Plaque percentage
The presence or absence of plaque is determinant, recorded as (+) in the presence of plaque or (-) in the absence of plaque, and the percentage of the entire mouth affected by plaque is expressed as a percentage (P%).
Measured: Baseline
Periodontal inflammatory surface area (PISA)
It is the calculation of the area of ulcerated periodontal pockets showing bleeding on probing based on the periodontal epithelial surface area.
Measured: Baseline
Salivary interleukin-10 (IL-10) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. Il-10 levels in saliva will be measured using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: Baseline
Salivary interleukin-1beta (IL-1β) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. IL-1β levels in saliva will be measured using the ELISA method.
Measured: Baseline
Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-3 levels in saliva will be measured using the ELISA method.
Measured: Baseline
Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-6 levels in saliva will be measured using the ELISA method.
Measured: Baseline
Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRP-12 levels in saliva will be measured using the ELISA method.
Measured: Baseline
Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levels
Saliva samples will be collected prior to clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analysis. NLRC-5 levels in saliva will be measured using the ELISA method.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start23 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
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.
- 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
- 116 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Karaduran, Uskudar University
- Investigators
- Kubra KARADURAN, Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312552
- Sponsor's protocol ID
- KKARADURAN1
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Periodontal Status and Smoking on Salivary Inflammasome Levels: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07312552
- Acronym / sponsor ID
- KKARADURAN1
- Conditions
- Periodontitis, Periodontal Disease, Periodontal Health, Smoking, Inflammasomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.
Detailed description
The aim of this study was to determine the periodontal status and smoking status of the participants, to obtain clinical periodontal records and to explain their relationship with salivary NLRP-3 NLRP-6, NLRP-12, NLRC-5, IL-1β and IL-10 levels.
The participants included in the study will be divided into four groups: smokers with periodontal disease, non-smokers with periodontal disease, smokers without periodontal disease, and non-smokers without periodontal disease. Systemic and dental anamnesis of the participants will be taken, smoking habits will be evaluated, medical records and current diagnoses will be examined, intraoral examinations will be performed and periodontal records will be taken. The periodontal status of the participants will be diagnosed according to the 'Classification of Periodontal and Peri-implant Diseases and Conditions' accepted at the 2017 World Workshop, supported by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP).
Saliva samples will be collected before clinical periodontal measurements. The collected saliva samples will be stored at -80°C until analyzed. Salivary NLRP-3, NLRP-6, NLRP-12, NLRC-5, IL1β, and IL-10 levels will be measured using an enzyme-linked immunosorbent assay (ELISA) method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (C) | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samplesHealthy individuals (control (C)) |
| Group 2 (S-C) | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samplesSmokers with healthy periodontium (S-C) |
| Group 3 (P) | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samplesNonsmokers with Stage III/IV periodontitis (P) |
| Group 4 (S-P) | – | Diagnostic Test: Periodontal examinations, Diagnostic Test: Collection of saliva samplesSmokers with Stage III/IV periodontitis (S-P) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will consist of four groups: Group 1: healthy individuals (control (C)), Group 2: smokers with healthy periodontium (S-C), Group 3: nonsmokers with Stage III/IV periodontitis (P), Group 4: smokers with Stage III/IV periodontitis (S-P)
Key inclusion criteria (3 listed)
- systemically healthy,
- clinical diagnosis of periodontitis,
- clinical diagnosis of periodontal health
Key exclusion criteria (6 listed)
- history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 6 months);
- nonsurgical periodontal treatment (previous 6 months);
- surgical periodontal treatment (previous 12 months);
- presence of <20 teeth;
- current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy);
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 |
|---|---|---|
| Periodontal examinationsWith periodontal evaluation, plaque percentage, probing pocket depth, percentage of bleeding on probing, clinical attachment level, number of teeth, periodontal inflammatory surface area (PISA) parameters are recorded. | Diagnostic test | Group 1 (C), Group 2 (S-C), Group 3 (P), Group 4 (S-P) |
| Collection of saliva samplesLevels of salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β), and interleukin-10 (IL-10) will be determined using an enzyme-linked immunosorbent assay (ELISA). | Diagnostic test | Group 1 (C), Group 2 (S-C), Group 3 (P), Group 4 (S-P) |
Primary outcome
Clinical attachment level (mm)
Time frame: Baseline
Clinical attachment level (CAL) is a more reliable indicator of periodontal support around a tooth than probing depth alone, as it is measured from a fixed anatomical landmark-the cementoenamel junction (CEJ)-which remains constant over time. Calculating CAL requires two measurements: the distance from the gingival margin to the CEJ and the probing depth. In cases of gingival recession, CAL is calculated by adding the probing depth to the distance from the gingival margin to the CEJ. In cases of gingival overgrowth, CAL is determined by subtracting the distance from the gingival margin to the CEJ from the probing depth.
Probing pocket depth
Time frame: Baseline
Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.
Bleeding on probing
Time frame: Baseline
The number obtained by dividing the sum of the positive areas by the sum of the examined areas is multiplied by 100 and the value obtained is expressed as the percentage of bleeding at probing (BOP%).
8 secondary outcomes
Plaque percentage
Time frame: Baseline
Periodontal inflammatory surface area (PISA)
Time frame: Baseline
Salivary interleukin-10 (IL-10) levels
Time frame: Baseline
Salivary interleukin-1beta (IL-1β) levels
Time frame: Baseline
Salivary NOD-like receptor family, pyrin domain containing 3 (NLRP-3) levels
Time frame: Baseline
Salivary NOD-like receptor family, pyrin domain containing 6 (NLRP-6) levels
Time frame: Baseline
Salivary NOD-like receptor family, pyrin domain containing 12 (NLRP-12) levels
Time frame: Baseline
Salivary NOD-like receptor family, CARD domain containing 5 (NLRC-5) levels
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Kubra KARADURAN principal investigator
Uskudar University
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 Disease, run by Uskudar 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 3 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: looking for participants now, as of the sponsor's last update on 21 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra KARADURAN (+905395913683, kubra95krdrn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (mm) (time frame: Baseline). The study lists 3 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 21 Jan 2026.