Impact of Smoking on Salivary Interleukin (IL)-39, IL-41, IL-1β, TNF-α Levels in Periodontal Disease

Necmettin Erbakan University100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Periodontitis, Adult Smoking Periodontal Diseases

Interventions

Saliva samples will be collected from all participants, and comprehensive clinical parameters will be meticulously documented. The Plaque Index (PI) and Gingival Index (GI) will be measured at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be recorded in detail for each tooth at six sites. The percentage of bleeding areas will be assessed within 20 seconds post-probing using a binary scoring system to indicate presence or absence. All clinical parameters will be recorded by a calibrated periodontologist utilizing manual probing techniques. Following collection, saliva samples will be stored at -80°C until subsequent analysis. Concentrations of IL-39, IL-41, IL-1β, and TNF-α in the saliva samples will be quantified using specific enzyme-linked immunosorbent assay (ELISA) kits.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The periodontitis groups (Non-smoking and smoking) in the study will include systemically healthy patients who are clinically diagnosed with Stage II and III, generalized, Grade B, C periodontitis based on the consensus report of the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions. * Agreeing to participate in the study Exclusion Criteria: * use of oral contraceptive drugs * use of antibiotics, immunosuppressants, or drug therapies in the last 6 months before the study; * history of excessive alcohol use; * pregnancy or breastfeeding status; * periodontal treatment during the last 6 months before the study. * Not agreeing to participate in the study * Not meeting the inclusion criteria

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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 (%)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: baseline