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OpenTrials
Completed

NCT Number: NCT07764549

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Medipol University, Faculty of Dentistry, Department of Periodontology

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Zehra Hasgül

Other

Registry information

Official study title

Salivary TNF-α, FoxO-1, and SIRT-1 Levels in Smokers and Non-Smokers With Stage III Periodontitis: A Case-Control Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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