Relationships Between Tenascin C, Smoking and Periodontal Status

Not yet recruiting

• Conditions: Periodontal Diseases; Smoking; Periodontitis
• Interventions: Diagnostic Test: Clinical Measurements and Saliva Sample Collection

• Registration Number: NCT06523205
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Study Start: 2024-08-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-smoking - periodontitis	Clinical Measurements and Saliva Sample Collection	participants who reported never smoking, with clinical attachment loss ≥3 mm in \>30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included.
smoking - periodontitis	Clinical Measurements and Saliva Sample Collection	participants who reported smoking \>10 cigarettes per day for \>5 years with clinical attachment loss ≥3 mm in \>30% of sites, with probing depth ≥5 mm in at least six teeth, and with radiographic bone loss extending to or beyond the middle third of the root in the coronal third will be included.
non-smoking - periodontally healthy	Clinical Measurements and Saliva Sample Collection	participants who reported never smoking and periodontal healthy.
smoking - periodontally healthy	Clinical Measurements and Saliva Sample Collection	participants who reported smoking \>10 cigarettes per day and periodontal healthy.

Primary Outcome Measures

Name	Time	Method
Periodontal clinical parameters (percentage bleeding on probing (BOP))	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) and Probing Pocket Depth (PPD))	baseline	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)
1.Periodontal clinical parameters (plaque index (PI) and gingival index (GI))	baseline	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
Levels of Tenascin C, IL-1β, IL-4 and IL-6 saliva samples	baseline	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.