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

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-08-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15

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

Name	Time	Method
Levels of IL-39, IL-41, IL-1β, and TNF-α saliva samples	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))	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)