Comparison of Salivary Neuropilin-1 (NRP-1), Cotinine and C-Reactive Protein (CRP) Levels With Periodontal Clinical Parameters in Smokers and Non-Smokers With Different Periodontal Diseases

Periodontal Diseases Clinical Trial

Official title:

Comparison of Salivary Neuropilin-1 (NRP-1), Cotinine and C-Reactive Protein (CRP) Levels With Periodontal Clinical Parameters in Smokers and Non-Smokers With Different Periodontal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459037
• Other study ID #: 2024-TDU-DISF-0001
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: April 14, 2025

Study information

• Verified date: June 2024
• Source: Izmir Katip Celebi University
• Contact: Seyma GÜNDOGDU
• Phone: 05532081776
• Email: seymaguundogdu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are analysed in tissues and fluids taken from the body. In various publications, the role of the glycoprotein sNRP-1 on inflammatory diseases and the relationship between smoking and periodontal diseases have been investigated. In this study, our aim was to evaluate the levels of this biomarker in the saliva of smokers with systemically healthy periodontitis and non-smokers with systemically healthy periodontitis, gingivitis and periodontal disease and to compare the concentration differences with CRP. Another aim is to show the effect of nicotine exposure rate on all these by measuring cotinine levels. In our study, all oral clinical parameters of 80 patients, including 20 systemically healthy, non-smoking and periodontally healthy patients, 20 patients with gingivitis, 20 patients with periodontitis; 20 systemically healthy, smoking patients with periodontitis, will be measured and saliva samples will be taken from the patients. The sNRP-1, cotinine and CRP levels in the samples will be determined by enzyme-linked immunoassay (ELISA). Then, statistical analyses will be performed and the difference in the levels of biomarkers between the groups will be interpreted. Possible significant differences between the levels of these biomarkers may reveal that sNRP-1 can be used as a diagnostic tool in periodontal diseases or as a guide for treatments to be performed and may reveal a new perspective on the relationship between periodontitis and smoking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 14, 2025
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) At least twenty permanent teeth in the mouth Non-smoker No medication for continuous use Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.

Not in pregnancy or lactation period. For the periodontitis group that has not received periodontal treatment in the last 6 months For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

• Any oral or systemic disease Regularly using a systemic medication During pregnancy or lactation Received periodontal treatment within the last 6 months. Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months Smokers are not included in the study

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Diagnostic Test:
• Saliva obtaining
The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. In 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.

Locations

Country	Name	City	State
Turkey	Izmir Katip Çelebi University Department of Periodontology	Izmir	Çigli

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of CRP in saliva	The total amount of CRP in saliva	24 hours after taking the clinical measurements at the first visit
Primary	The total amount of Neuropilin-1(NRP-1) in saliva	The total amount of Neuropilin-1(NRP-1) in saliva	24 hours after taking the clinical measurements at the first visit
Primary	The total amount of , Cotinine in saliva	The total amount of , Cotinine in saliva	24 hours after taking the clinical measurements at the first visit