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
• Interventions: Diagnostic Test: Clinical Measurements and Saliva Sample Collection

• 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

Arm && Interventions

Group	Intervention	Description
non-smoking - periodontitis	Clinical Measurements and Saliva Sample Collection	Non-smokers: Only participants who have reported never smoking will be considered. Clinical Attachment Loss: Participants must exhibit a clinical attachment loss (CAL) of ≥3 mm in more than 30% of sites. Probing Depth: A probing depth (PD) of ≥5 mm must be present in at least six teeth. Radiographic Bone Loss: Participants must show radiographic evidence of bone loss extending to or beyond the middle third of the root in the coronal third.
non-smoking - periodontally healthy	Clinical Measurements and Saliva Sample Collection	Participants eligible for inclusion are those who have reported a lifetime history of never smoking and exhibit periodontal health.
smoking - periodontally healthy	Clinical Measurements and Saliva Sample Collection	Tobacco Use: Participants must have a documented history of smoking more than 10 cigarettes per day. Periodontal Health: Participants must exhibit clinically verified periodontal health, characterized by the absence of clinical attachment loss, probing depths within normal ranges, and no radiographic evidence of alveolar bone loss.
smoking - periodontitis	Clinical Measurements and Saliva Sample Collection	Smoking History: Participants must have reported smoking more than 10 cigarettes per day for a period exceeding 5 years. Clinical Attachment Loss (CAL): Participants must exhibit a clinical attachment loss of ≥3 mm in more than 30% of examined sites. Probing Depth (PD): A probing depth of ≥5 mm must be present in at least six teeth. Radiographic Bone Loss: Participants must demonstrate radiographic evidence of bone loss extending to or beyond the middle third of the root in the coronal third.

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)