Impact of Smoking on Salivary Interleukin (IL)-39, IL-41, IL-1β, TNF-α Levels in Periodontal Disease
NCT Number: NCT06528522
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Periodontitis, Adult|Smoking|Periodontal Diseases
Interventions: DIAGNOSTIC_TEST: Clinical Measurements and Saliva Sample Collection
Sponsor: Necmettin Erbakan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-01
Completion Date: 2024-09-15

Summary:
The goal of this observational study is to evaluate if the measurement of salivary Interleukin (IL)-39, IL-41, IL-1Beta(β), and Tumor necrosis factor-alpha (TNF-α) levels can aid in the early diagnosis of periodontitis in patients with varying periodontal conditions, both smokers and non-smokers. The main questions it aims to answer are:

Can salivary IL-39, IL-41, IL-1β, and TNF-α levels be used as biomarkers for the early diagnosis of periodontitis? How do IL-41 and IL-39 levels correlate with smoking status in periodontal healthy and periodontitis patients? Researchers will compare the salivary biomarker levels between smokers and non-smokers to see if smoking affects these levels.

Participants will:

Provide salivary samples for biomarker analysis. Undergo a comprehensive periodontal examination to determine their periodontal status.

Primary Outcome Measures: Periodontal clinical parameters (plaque index (PI)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Plaque Index (PI) Unit: Numerical score, baseline|Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samples, Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samples (ng/L) Unit: Picograms per milliliter (pg/mL)

IL-39, IL-41, IL-1β, and TNF-α levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method., baseline|Periodontal clinical parameters (percentage bleeding on probing (BOP)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include percentage bleeding on probing (BOP) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Percentage Bleeding on Probing (BOP) Unit: Percentage (%), baseline|Periodontal clinical parameters (Clinical Attachment Level (CAL)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include clinical attachment level (CAL) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Clinical Attachment Level (CAL) Unit: Millimeters (mm), baseline|Periodontal clinical parameters (gingival index (GI)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include gingival index (GI) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Gingival Index (GI) Unit: Numerical score, baseline|Periodontal clinical parameters (Probing Pocket Depth (PPD)), The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include probing pocket depth (PPD) at six sites per tooth (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual) on each tooth.

Probing Pocket Depth (PPD) Unit: Millimeters (mm), baseline