Impact of Smoking on Salivary Inflammatory Cytokines (Interleukin (IL)-39, IL-41, IL-1β, TNF-α) in Periodontal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Necmettin Erbakan University
- Enrollment
- 100
- Primary Endpoint
- Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samples
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samples
Time Frame: baseline
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))
Time Frame: 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))
Time Frame: 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))
Time Frame: 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))
Time Frame: 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))
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Osman Babayigit
Assistant Professor
Necmettin Erbakan University