Relationships Between Tenascin C, Smoking and Periodontal Status

N/ANot Yet RecruitingNCT06523205

Necmettin Erbakan University100 enrolled

Overview

The goal of this observational study is to determine if there is a relationship between different periodontal conditions (gingival healthy, stage 2 grade B, stage 2 grade C, stage 3 grade B, stage 3 grade C) and the levels of tenascin C, IL-1 beta, IL-4, and IL-6 in saliva samples from smokers and non-smokers. The main questions it aims to answer are: Is there a difference in the levels of tenascin C, IL-1 beta, IL-4, and IL-6 between smokers and non-smokers with different periodontal conditions? Do these biomarkers correlate with the severity and grade of periodontal disease? Researchers will compare the saliva samples from smokers and non-smokers across the different periodontal conditions to see if there are significant differences in the biomarker levels. Participants will: Provide saliva samples. Be categorized based on their smoking status and periodontal condition.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Periodontitis Smoking Periodontal Diseases

Interventions

Saliva samples will be collected from all patients. Clinical parameters will also be recorded. Plaque index (PI) and gingival index (GI) will be recorded at four sites per tooth. Full-mouth probing depth (PD) and clinical attachment level (CAL) will be detailed per tooth at six sites, and the percentage of bleeding areas will be recorded as present or absent within 20 seconds after probing using a binary scoring system. A calibrated periodontologist will record all clinical parameters using manual probing. Following sampling, saliva samples will be stored at -80°C until analysis. Concentrations of Tenascin-C, IL-4, IL-6, and IL-1beta will be analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits in saliva samples.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))

The measurements will be performed using a Williams periodontal probe (Hu-Friedy, Chicago, IL, USA) and will include plaque index (PI) and 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 Plaque Index (PI) Unit: Numerical score

Time frame: baseline

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 (%)

Time frame: baseline

Periodontal clinical parameters (Clinical Attachment Level (CAL) and 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) and 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) Probing Pocket Depth (PPD) Unit: Millimeters (mm)

Time frame: baseline

Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples

Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples (ng/L) Unit: Picograms per milliliter (pg/mL) Tenascin C, IL-1β, IL-4 and IL-6 levels will be assayed with commercially available kits using the enzyme-linked immunosorbent assay (ELISA) method.

Time frame: baseline