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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06528522
Enrollment
100
Registered
2024-07-30
Start date
2024-08-01
Completion date
2024-09-15
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Periodontitis, Adult, Smoking

Keywords

periodontitis, cytokines, saliva

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.

Interventions

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.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Periodontal clinical parameters (plaque index (PI))baselineThe 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 samplesbaselineLevels 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))baselineThe 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))baselineThe 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))baselineThe 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))baselineThe 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026