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

NCT ID: NCT06528522

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-09-15

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.

Conditions

Periodontitis, Adult; Smoking; Periodontal Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

non-smoking - periodontally healthy

Participants eligible for inclusion are those who have reported a lifetime history of never smoking and exhibit periodontal health.

Clinical Measurements and Saliva Sample Collection

Intervention Type: 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.

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.

Clinical Measurements and Saliva Sample Collection

Intervention Type: 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.

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.

Clinical Measurements and Saliva Sample Collection

Intervention Type: 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.

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.

Clinical Measurements and Saliva Sample Collection

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Osman Babayigit

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IL-39-41-Smoke-Periodontitis

Identifier Type: -

Identifier Source: org_study_id