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

NCT07764549 | Completed

• 1 other identifier: ZH-2026-TNF-FoxO1-SIRT1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis (Stage 3); Smoking ( Cigarette)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 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 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 at a single time point at study enrollment

Study Arms (4)

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

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.

Non-Smoking, Periodontally Healthy; Non-Smoking, Stage III Periodontitis; Smoking, Periodontally Healthy; Smoking, Stage III Periodontitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zehra Hasgül: lead

Study Sites (1)

İstanbul Medipol University, Faculty of Dentistry, Department of Periodontology

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Cigarette Smoking; Smoking; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tobacco Smoking; Behavior; Tobacco Use; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, Periodontist, Research Assistant

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: October 24, 2025
• Primary Completion: March 24, 2026
• Study Completion: May 24, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)