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CompletedNCT07764549Updated Aug 14, 2026

Salivary TNF-α, FoxO-1, and SIRT-1 Levels in Periodontitis and Smoking

An observational study in Periodontitis (Stage 3) and Smoking ( Cigarette), sponsored by Zehra Hasgül. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Zehra Hasgül · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Periodontitis (Stage 3)
  • Smoking ( Cigarette)

Keywords

  • Periodontitis
  • Smoking
  • Saliva
  • TNF- alpha
  • FoxO-1
  • SIRT-1
  • Oxidative stress
  • Biomarkers
  • Inflammation
03

In context

Periodontitis

1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 372 observational studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Zehra Hasgül is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-Smoking, Periodontally Healthy

    Systemically healthy, non-smoking participants with no clinical signs of periodontal disease (probing depth ≤3 mm, bleeding on probing \<10%).

    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.

    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).

    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).

    Diagnostic Test: Salivary Biomarker Analysis (ELISA)

Interventions

  • Diagnostic testSalivary 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at a single time point at study enrollment

  2. 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.

    Time frame: Measured at a single time point at study enrollment

  3. 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.

    Time frame: Measured at a single time point at study enrollment

07

Study locations

1 site
  • İstanbul Medipol University, Faculty of Dentistry, Department of Periodontology
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2025 to primary completion in Mar 2026, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2026
First posted
Aug 14, 2026
StartActual
Oct 24, 2025
Primary completionActual
Mar 24, 2026
CompletionActual
May 24, 2026
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07764549
Lead sponsor
Zehra Hasgül
Responsible party
Zehra Hasgül (DDS, Periodontist, Research Assistant, Ankara University) — Sponsor-investigator
First posted
Aug 14, 2026
Start date
Oct 24, 2025
Primary completion
Mar 24, 2026
Completion
May 24, 2026
Last update
Aug 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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