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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Smoking; Periodontal Diseases; Periodontitis, Adult
• Intervention / Treatment: Diagnostic test: Clinical Measurements and Saliva Sample Collection

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included will be evaluated by Assistant Professor Dr. Osman BABAYIGIT at the Periodontology Clinic of NEU Faculty of Dentistry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-smoking - periodontally healthy; Participants eligible for inclusion are those who have reported a lifetime history of never smoking and exhibit periodontal health.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
smoking - periodontally healthy; 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.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
non-smoking - periodontitis; 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.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
smoking - periodontitis; 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.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	baseline
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	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.	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)	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	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)	baseline

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; cytokines; saliva
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Periodontal Diseases; Chronic Periodontitis
• Other Study ID Numbers: IL-39-41-Smoke-Periodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No