PeriodontitisNCT07563192
Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis
An observational study of Periodontitis and Gingivitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Gingivitis, Periodontal Diseases
- Type of treatment
- Injection or infusion
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 30 Jun 2026
- 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 population consists of individuals who applied to the Department of Periodontology at the Faculty of Dentistry. Participants include systemically healthy volunteers diagnosed with different periodontal conditions (healthy, gingivitis, or periodontitis) and categorized by their smoking status.
Who may be able to join
- Individuals who voluntarily agreed to participate in the study,
- Smokers (gingivitis and stage 3/4 generalized periodontitis) and non-smokers (gingivitis and stage 3/4 generalized periodontitis) who applied to the Periodontology Clinical of Suleyman Demirel University Faculty of Dentistry,
- Individuals without any systemic diseases and without using any medications that affect periodontal health were included.
Who cannot join
- Individuals who refuse to participate in the study or who cannot comply with the study protocol,
- Individuals participating in another clinical trial concurrently, Individuals who have received periodontal treatment within the last 6 months,
- Individuals who have used medications (antibiotics, anti-inflammatory drugs, etc.) that may affect periodontal parameters within the last 3 months,
- Individuals with systemic diseases that may affect the periodontium,
- Individuals with systemic diseases presenting with oral symptoms,
- Individuals with malignant disease,
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- Pregnant or lactating women,
- Individuals with psychological or physical disabilities,
- Individuals with substance abuse,
- Individuals with severe malocclusion, undergoing orthodontic treatment, using appliances, or using removable dentures,
- Individuals with acute dental infection or pain (cavities, abscesses, etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University, Faculty of Dentistry, Department of Periodontology
Isparta, Isparta, 32000
About this study
This study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and Periodontitis. The study specifically evaluates the levels of IL-1beta, IL-18, and NLRP3 through ELISA, and the gene expression of TLR1, TLR4, and TLR6 through RT-PCR, to understand how cigarette smoke modulates innate immune responses in the absence of other systemic diseases.
Read the detailed description
The aim of this research is to clarify the molecular link between tobacco use and pyroptotic cell death pathways in the pathogenesis of periodontal disease. To eliminate systemic bias, only systemically healthy participants are included. The study design consists of 6 distinct groups based on a 2x3 matrix (Smoking Status: Yes/No × Periodontal Status: Healthy/Gingivitis/Periodontitis).
Protein levels of the NLRP3 inflammasome and pro-inflammatory cytokines (IL-1beta, IL-18) are measured in periodontal tissues using the ELISA method. Furthermore, the mRNA expressions of Toll-like receptors (TLR1, TLR4, and TLR6) are analyzed via RT-PCR. These findings will help determine how smoking influences tissue destruction mechanisms specifically through the pyroptosis pathway in different stages of gum disease.
- Conditions
- Periodontitis, Gingivitis, Periodontal Diseases, Smoking ( Cigarette)
- Keywords
- pyroptosis, NLRP3 Inflammasome, Interleukin-1 beta ( IL-1β), Interleukin-18 (IL-18), Cigarette Smoking, TLR1, TLR4, TLR6
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases, Cigarette Smoking
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 |
|---|---|---|
| Healthy Non-Smoker | Systemically healty individulas with clinically healthy periodontal tissues who have never smoked or have not smoked for least 5 years. | |
| Gingivitis Non-Smoker | Systemically healty individulas diagnosed with gingivitis who are non-smokers. | |
| Periodontitis Non-Smoker | Systemically healty individulas diagnosed with Stage III or IV periodontitis who are non-smokers. | |
| Healthy Smoker | Systemically healty individulas with clinically healthy periodontal tissues who have been smoking least 10 cigarettes per day for at least 1 year. | |
| Gingivitis Smoker | Systemically healty individulas with gingivitis who have been smoking least 10 cigarettes per day for at least 1 year. | |
| Periodontitis Smoker | Systemically healty individulas diagnosed with Stage III or IV periodontitis who who have been smoking least 10 cigarettes per day for at least 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative mRNA expression levels of TLR1,TLR4 and TLR6
Metric:Fold change (2^-ΔΔCt method). Measurement of gene expression levels in gingival tissues using the RT-PCR method.
Measured: Baseline (At the clinical examination)
Protein concerntrations of NLRP3, IL-18 and IL-1β
Metric: Picograms per milliliter (pg/mL). Evaluation of protein concentrations in gingival tissue samples using the ELISA method.
Measured: Baseline (At the time of clinical examinat
Secondary outcomes (3)
Periodontal Inflamed Surface Area (PISA)
Metric: square millimeters (mm²). Calculation of the total periodontal inflamed surface area to quantify the inflammatory burden.
Measured: Baseline (At the time of clinical examination)
Periodontal Clinical Measurements (PD and CAL)
Metric: millimeters (mm). Measurements of Probing Depth (PD) and Clinical Attachment Level (CAL) using a periodontal probe.
Measured: Baseline (At the time of clinical examination)
Periodontal Indices (PI and GI)
Metric: 0-3 numerical scale. Assessment of Plaque Index (PI) and Gingival Index (GI) to evaluate oral hygiene and gingival inflammation.
Measured: Baseline (At the time of clinical examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Oct 2024
- Primary completion18 Nov 2025
- Study completion30 Jun 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem KOKSALAN, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563192
- Sponsor's protocol ID
- 79-38
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis
- ClinicalTrials.gov ID
- NCT07563192
- Acronym / sponsor ID
- 79-38
- Conditions
- Periodontitis, Gingivitis, Periodontal Diseases, Smoking ( Cigarette)
- Keywords
- pyroptosis, NLRP3 Inflammasome, Interleukin-1 beta ( IL-1β), Interleukin-18 (IL-18), Cigarette Smoking, TLR1, TLR4, TLR6
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 May 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 study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and Periodontitis. The study specifically evaluates the levels of IL-1beta, IL-18, and NLRP3 through ELISA, and the gene expression of TLR1, TLR4, and TLR6 through RT-PCR, to understand how cigarette smoke modulates innate immune responses in the absence of other systemic diseases.
Detailed description
The aim of this research is to clarify the molecular link between tobacco use and pyroptotic cell death pathways in the pathogenesis of periodontal disease. To eliminate systemic bias, only systemically healthy participants are included. The study design consists of 6 distinct groups based on a 2x3 matrix (Smoking Status: Yes/No × Periodontal Status: Healthy/Gingivitis/Periodontitis).
Protein levels of the NLRP3 inflammasome and pro-inflammatory cytokines (IL-1beta, IL-18) are measured in periodontal tissues using the ELISA method. Furthermore, the mRNA expressions of Toll-like receptors (TLR1, TLR4, and TLR6) are analyzed via RT-PCR. These findings will help determine how smoking influences tissue destruction mechanisms specifically through the pyroptosis pathway in different stages of gum disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Non-Smoker | – | –Systemically healty individulas with clinically healthy periodontal tissues who have never smoked or have not smoked for least 5 years. |
| Gingivitis Non-Smoker | – | –Systemically healty individulas diagnosed with gingivitis who are non-smokers. |
| Periodontitis Non-Smoker | – | –Systemically healty individulas diagnosed with Stage III or IV periodontitis who are non-smokers. |
| Healthy Smoker | – | –Systemically healty individulas with clinically healthy periodontal tissues who have been smoking least 10 cigarettes per day for at least 1 year. |
| Gingivitis Smoker | – | –Systemically healty individulas with gingivitis who have been smoking least 10 cigarettes per day for at least 1 year. |
| Periodontitis Smoker | – | –Systemically healty individulas diagnosed with Stage III or IV periodontitis who who have been smoking least 10 cigarettes per day for at least 1 year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals who applied to the Department of Periodontology at the Faculty of Dentistry. Participants include systemically healthy volunteers diagnosed with different periodontal conditions (healthy, gingivitis, or periodontitis) and categorized by their smoking status.
Key inclusion criteria (3 listed)
- Individuals who voluntarily agreed to participate in the study,
- Smokers (gingivitis and stage 3/4 generalized periodontitis) and non-smokers (gingivitis and stage 3/4 generalized periodontitis) who applied to the Periodontology Clinical of Suleyman Demirel University Faculty of Dentistry,
- Individuals without any systemic diseases and without using any medications that affect periodontal health were included.
Key exclusion criteria (11 listed)
- Individuals who refuse to participate in the study or who cannot comply with the study protocol,
- Individuals participating in another clinical trial concurrently, Individuals who have received periodontal treatment within the last 6 months,
- Individuals who have used medications (antibiotics, anti-inflammatory drugs, etc.) that may affect periodontal parameters within the last 3 months,
- Individuals with systemic diseases that may affect the periodontium,
- Individuals with systemic diseases presenting with oral symptoms,
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
Relative mRNA expression levels of TLR1,TLR4 and TLR6
Time frame: Baseline (At the clinical examination)
Metric:Fold change (2^-ΔΔCt method). Measurement of gene expression levels in gingival tissues using the RT-PCR method.
Protein concerntrations of NLRP3, IL-18 and IL-1β
Time frame: Baseline (At the time of clinical examinat
Metric: Picograms per milliliter (pg/mL). Evaluation of protein concentrations in gingival tissue samples using the ELISA method.
3 secondary outcomes
Periodontal Inflamed Surface Area (PISA)
Time frame: Baseline (At the time of clinical examination)
Periodontal Clinical Measurements (PD and CAL)
Time frame: Baseline (At the time of clinical examination)
Periodontal Indices (PI and GI)
Time frame: Baseline (At the time of clinical examination)
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 1 May 2026.
- Individual participant dataSharing planned: No
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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 Gingivitis, run by Suleyman Demirel 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 11 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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?
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?
Relative mRNA expression levels of TLR1,TLR4 and TLR6 (time frame: Baseline (At the clinical examination)). 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 1 May 2026.