Periodontitis (Stage 3)NCT07764549
Salivary TNF-α, FoxO-1, and SIRT-1 Levels in Periodontitis and Smoking
An observational study of Periodontitis (Stage 3) and Smoking ( Cigarette), run by Zehra Hasgül at 1 site in Turkey (Türkiye).
Trial summary
This study examines whether smoking and gum disease (periodontitis) are linked to changes in three biological markers found in saliva: TNF-α, FoxO-1, and SIRT-1. These markers are involved in inflammation and the body's response to stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis (Stage 3), Smoking ( Cigarette)
- What is being tested?
- Salivary Biomarker Analysis (ELISA)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2025to 24 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically healthy adults aged ≥18 years recruited from the Department of Periodontology, Faculty of Dentistry, İstanbul Medipol University, stratified into four groups (n=20 each) based on periodontal status (healthy vs. Stage III periodontitis) and smoking status (smoker vs. non-smoker, verified by salivary cotinine concentration).
Who may be able to join
- Aged 18 years or older
- At least 16 permanent teeth, excluding third molars
- Not receiving orthodontic treatment
- No systemic condition known to affect periodontal health
Who cannot join
- Pregnant or breastfeeding
- Diabetes mellitus, rheumatoid arthritis, hypertension, or another systemic disease that could influence periodontal tissues
- Periodontal treatment within the previous six months
- Use of antibiotics or anti-inflammatory medications within the previous six months
- Any local or systemic condition that could affect salivary biomarker concentrations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medipol University, Faculty of Dentistry, Department of Periodontology
Istanbul
About this study
Official title: Salivary TNF-α, FoxO-1, and SIRT-1 Levels in Smokers and Non-Smokers With Stage III Periodontitis: A Case-Control Study
This study examines whether smoking and gum disease (periodontitis) are linked to changes in three biological markers found in saliva: TNF-α, FoxO-1, and SIRT-1. These markers are involved in inflammation and the body's response to stress.
Eighty adults took part in the study, divided into four groups: healthy non-smokers, non-smokers with Stage III periodontitis (an advanced form of gum disease), healthy smokers, and smokers with Stage III periodontitis. Each participant had a dental examination and provided a saliva sample, which was analyzed in the laboratory to measure the levels of these three markers.
The goal of the study is to better understand how smoking and gum disease together affect the body's inflammatory and stress-response pathways, which may help guide future approaches to prevention and treatment.
- Conditions
- Periodontitis (Stage 3), Smoking ( Cigarette)
- Being tested
- Salivary Biomarker Analysis (ELISA)
- Keywords
- Periodontitis, Smoking, Saliva, TNF- alpha, FoxO-1, SIRT-1, Oxidative stress, Biomarkers, Inflammation
- Medical subject headings
- Periodontitis, Cigarette Smoking, Smoking, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary Biomarker Analysis (ELISA)Diagnostic test
Unstimulated whole saliva samples were collected via passive drooling and analyzed for TNF-α, FoxO-1, and SIRT-1 concentrations using commercially available enzyme-linked immunosorbent assay (ELISA) kits (BT LAB, Korain Biotech, Shanghai, China), according to the manufacturer's instructions. Concentrations were adjusted according to individual salivary flow rate.
| Study group | Role | What they receive |
|---|---|---|
| Non-Smoking, Periodontally Healthy | Systemically healthy, non-smoking participants with no clinical signs of periodontal disease (probing depth ≤3 mm, bleeding on probing <10%). Receives: Diagnostic Test: Salivary Biomarker Analysis (ELISA) | |
| Non-Smoking, Stage III Periodontitis | Systemically healthy, non-smoking participants diagnosed with Stage III periodontitis, defined by interdental clinical attachment loss ≥5 mm at the site of greatest loss, radiographic bone loss extending to the middle third of the root or beyond, and probing depth ≥6 mm. Receives: Diagnostic Test: Salivary Biomarker Analysis (ELISA) | |
| Smoking, Periodontally Healthy | Systemically healthy smokers with no clinical signs of periodontal disease (probing depth ≤3 mm, bleeding on probing <10%). Smoking status was self-reported and verified by salivary cotinine concentration (>0.18 mg/L). Receives: Diagnostic Test: Salivary Biomarker Analysis (ELISA) | |
| Smoking, Stage III Periodontitis | Smokers diagnosed with Stage III periodontitis, defined by interdental clinical attachment loss ≥5 mm at the site of greatest loss, radiographic bone loss extending to the middle third of the root or beyond, and probing depth ≥6 mm. Smoking status was self-reported and verified by salivary cotinine concentration (>0.18 mg/L). Receives: Diagnostic Test: Salivary Biomarker Analysis (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary TNF-α Concentration
Salivary TNF-α concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/L, adjusted for individual salivary flow rate.
Measured: Measured at a single time point at study enrollment
Salivary FoxO-1 Concentration
Salivary FoxO-1 concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/mL, adjusted for individual salivary flow rate.
Measured: Measured at a single time point at study enrollment
Salivary SIRT-1 Concentration
Salivary SIRT-1 concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/mL, adjusted for individual salivary flow rate.
Measured: Measured at a single time point at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start24 Oct 2025
- Primary completion24 Mar 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zehra Hasgül
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zehra Hasgül, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764549
- Sponsor's protocol ID
- ZH-2026-TNF-FoxO1-SIRT1
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary TNF-α, FoxO-1, and SIRT-1 Levels in Smokers and Non-Smokers With Stage III Periodontitis: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07764549
- Acronym / sponsor ID
- ZH-2026-TNF-FoxO1-SIRT1
- Conditions
- Periodontitis (Stage 3), Smoking ( Cigarette)
- Keywords
- Periodontitis, Smoking, Saliva, TNF- alpha, FoxO-1, SIRT-1, Oxidative stress, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zehra HasgülUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 14 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 study examines whether smoking and gum disease (periodontitis) are linked to changes in three biological markers found in saliva: TNF-α, FoxO-1, and SIRT-1. These markers are involved in inflammation and the body's response to stress.
Eighty adults took part in the study, divided into four groups: healthy non-smokers, non-smokers with Stage III periodontitis (an advanced form of gum disease), healthy smokers, and smokers with Stage III periodontitis. Each participant had a dental examination and provided a saliva sample, which was analyzed in the laboratory to measure the levels of these three markers.
The goal of the study is to better understand how smoking and gum disease together affect the body's inflammatory and stress-response pathways, which may help guide future approaches to prevention and treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Smoking, Periodontally Healthy | – | Diagnostic Test: Salivary Biomarker Analysis (ELISA)Systemically healthy, non-smoking participants with no clinical signs of periodontal disease (probing depth ≤3 mm, bleeding on probing <10%). |
| Non-Smoking, Stage III Periodontitis | – | Diagnostic Test: Salivary Biomarker Analysis (ELISA)Systemically healthy, non-smoking participants diagnosed with Stage III periodontitis, defined by interdental clinical attachment loss ≥5 mm at the site of greatest loss, radiographic bone loss extending to the middle third of the root or beyond, and probing depth ≥6 mm. |
| Smoking, Periodontally Healthy | – | Diagnostic Test: Salivary Biomarker Analysis (ELISA)Systemically healthy smokers with no clinical signs of periodontal disease (probing depth ≤3 mm, bleeding on probing <10%). Smoking status was self-reported and verified by salivary cotinine concentration (>0.18 mg/L). |
| Smoking, Stage III Periodontitis | – | Diagnostic Test: Salivary Biomarker Analysis (ELISA)Smokers diagnosed with Stage III periodontitis, defined by interdental clinical attachment loss ≥5 mm at the site of greatest loss, radiographic bone loss extending to the middle third of the root or beyond, and probing depth ≥6 mm. Smoking status was self-reported and verified by salivary cotinine concentration (>0.18 mg/L). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy adults aged ≥18 years recruited from the Department of Periodontology, Faculty of Dentistry, İstanbul Medipol University, stratified into four groups (n=20 each) based on periodontal status (healthy vs. Stage III periodontitis) and smoking status (smoker vs. non-smoker, verified by salivary cotinine concentration).
Key inclusion criteria (4 listed)
- Aged 18 years or older
- At least 16 permanent teeth, excluding third molars
- Not receiving orthodontic treatment
- No systemic condition known to affect periodontal health
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding
- Diabetes mellitus, rheumatoid arthritis, hypertension, or another systemic disease that could influence periodontal tissues
- Periodontal treatment within the previous six months
- Use of antibiotics or anti-inflammatory medications within the previous six months
- Any local or systemic condition that could affect salivary biomarker concentrations
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 |
|---|---|---|
| Salivary Biomarker Analysis (ELISA)Unstimulated whole saliva samples were collected via passive drooling and analyzed for TNF-α, FoxO-1, and SIRT-1 concentrations using commercially available enzyme-linked immunosorbent assay (ELISA) kits (BT LAB, Korain Biotech, Shanghai, China), according to the manufacturer's instructions. Concentrations were adjusted according to individual salivary flow rate. | Diagnostic test | Non-Smoking, Periodontally Healthy, Non-Smoking, Stage III Periodontitis, Smoking, Periodontally Healthy, Smoking, Stage III Periodontitis |
Primary outcome
Salivary TNF-α Concentration
Time frame: Measured at a single time point at study enrollment
Salivary TNF-α concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/L, adjusted for individual salivary flow rate.
Salivary FoxO-1 Concentration
Time frame: Measured at a single time point at study enrollment
Salivary FoxO-1 concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/mL, adjusted for individual salivary flow rate.
Salivary SIRT-1 Concentration
Time frame: Measured at a single time point at study enrollment
Salivary SIRT-1 concentration measured by enzyme-linked immunosorbent assay (ELISA), expressed as ng/mL, adjusted for individual salivary flow rate.
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 14 Aug 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 (Stage 3) and Smoking ( Cigarette), run by Zehra Hasgül 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 4 inclusion and 5 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 14 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 TNF-α Concentration (time frame: Measured at a single time point at study enrollment). 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 14 Aug 2026.