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

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Key information

Conditions

Periodontitis, Adult Behavior Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Smoking Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Measurements and Saliva Sample Collection

Diagnostic Test

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.

Primary outcomes

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
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 (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 (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 (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 (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)

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jul 30, 2024
Registry last updated: Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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