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

Not yet recruiting
Conditions
Periodontal Diseases
Periodontitis, Adult
Smoking
Registration Number
NCT06528522
Lead Sponsor
Necmettin Erbakan University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samplesbaseline

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.

Periodontal clinical parameters (Clinical Attachment Level (CAL))baseline

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)

Periodontal clinical parameters (percentage bleeding on probing (BOP))baseline

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 (%)

Periodontal clinical parameters (gingival index (GI))baseline

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

Periodontal clinical parameters (plaque index (PI))baseline

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

Periodontal clinical parameters (Probing Pocket Depth (PPD))baseline

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)

Secondary Outcome Measures
NameTimeMethod

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