Relationships Between Tenascin C, Smoking and Periodontal Status

Evaluation of the Relationships Between Salivary Tenascin C ,IL-4, IL-6, and IL-1β Levels, Smoking and Periodontal Status

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 Overview

• Status: Not yet recruiting
• Conditions: Smoking; Periodontitis; Periodontal Diseases
• Intervention / Treatment: Diagnostic test: Clinical Measurements and Saliva Sample Collection

• Study Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study is planned to be conducted with 100 individuals aged between 18 and 65 who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University, for various reasons. The eligibility of individuals to be included will be evaluated by Assistant Professor Dr. Osman BABAYIGIT at the Periodontology Clinic of NEU Faculty of Dentistry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-smoking - periodontally healthy; participants who reported never smoking and periodontal healthy.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
smoking - periodontally healthy; participants who reported smoking >10 cigarettes per day and periodontal healthy.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
non-smoking - periodontitis; 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.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.
smoking - periodontitis; 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.	Diagnostic test: Clinical Measurements and Saliva Sample Collection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 (%)	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)	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.	baseline

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: periodontitis; cytokines; saliva
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: tenascincsmokeperiodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No