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Comparison of Salivary Biormarkers Levels With Periodontal Clinical Parameters in Smokers and Non-Smokers With Different Periodontal Diseases

NCT06459037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-21

No results posted yet for this study

Summary

To better understand the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are commonly analyzed in tissues and biological fluids collected from the body. The role of the glycoprotein neuropilin-1 (NRP-1) in inflammatory diseases, as well as the relationship between smoking and periodontal diseases, has been investigated in several studies.

The primary aim of this study is to evaluate the salivary levels of NRP-1 in systemically healthy individuals, including non-smokers with periodontal health, non-smokers with gingivitis, non-smokers with periodontitis, and smokers with periodontitis. Additionally, the study aims to compare the concentration of NRP-1 with C-reactive protein (CRP) levels across these groups to assess potential associations.

A secondary objective is to determine the impact of nicotine exposure by measuring salivary cotinine levels and exploring their relationship with the clinical and biochemical parameters assessed. The study will include a total of 80 participants, divided into four equal groups: 20 non-smokers with periodontal health, 20 patients with gingivitis, 20 non-smokers with periodontitis, and 20 smokers with periodontitis.

For all participants, comprehensive oral clinical parameters will be recorded, and unstimulated saliva samples will be collected. The concentrations of NRP-1, cotinine, and CRP in these samples will be determined using enzyme-linked immunosorbent assay (ELISA). Statistical analyses will then be conducted to evaluate differences in biomarker levels among the groups.

Significant variations in these biomarker levels may indicate that NRP-1 has potential utility as a diagnostic biomarker for periodontal diseases or as a marker to guide treatment strategies. Furthermore, the findings may contribute to a deeper understanding of the interplay between periodontitis and smoking.

Conditions

  • Periodontal Diseases

Interventions

DIAGNOSTIC_TEST

Saliva obtaining

The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    lead OTHER

Principal Investigators

  • Abdullah Seçkin Ertuğrul, Prof. Dr. · Izmir Katip Çelebi University, Faculty of Dentistry, Department of Periodontology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2024-11-25
Completion
2025-03-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06459037 on ClinicalTrials.gov