Relationships Between Tenascin C, Smoking and Periodontal Status

NCT06523205 | Not Yet Recruiting

• 1 other identifier: tenascincsmokeperiodontitis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis; Smoking; Periodontal Diseases

Keywords

periodontitis; cytokines; saliva

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

non-smoking - periodontally healthy

participants who reported never smoking and periodontal healthy.

Diagnostic Test: Clinical Measurements and Saliva Sample Collection

smoking - periodontally healthy

participants who reported smoking \>10 cigarettes per day and periodontal healthy.

Diagnostic Test: Clinical Measurements and Saliva Sample Collection

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

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

Interventions

Clinical Measurements and Saliva Sample Collection DIAGNOSTIC_TEST

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 - periodontally healthy; non-smoking - periodontitis; smoking - periodontally healthy; smoking - periodontitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Periodontitis; Smoking; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 15, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07