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

Necmettin Erbakan University

Status: Not yet enrolling

Conditions: Periodontal Diseases; Smoking; Periodontitis, Adult

Treatments: Diagnostic Test: Clinical Measurements and Saliva Sample Collection

Study type: Observational

Funder types: Other

Identifiers

NCT06528522

IL-39-41-Smoke-Periodontitis

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 4 patient groups

non-smoking - periodontally healthy

Description:

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

Treatment:

Diagnostic Test: Clinical Measurements and Saliva Sample Collection

smoking - periodontally healthy

Description:

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.

Treatment:

Diagnostic Test: Clinical Measurements and Saliva Sample Collection

non-smoking - periodontitis

Description:

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.

Treatment:

Diagnostic Test: Clinical Measurements and Saliva Sample Collection

smoking - periodontitis

Description:

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.

Treatment:

Diagnostic Test: Clinical Measurements and Saliva Sample Collection