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

NCT06459037 | Completed

• 1 other identifier: 2024-TDU-DİŞF-0001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontitis; gingivitis; neuropilin-1; crp; cotinine; smoking; biomarker; saliva; salivary; ELISA

Outcome Measures

Primary Outcomes (3)

• salivary CRP level

  The total amount of CRP in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary Neuropilin-1 level

  The total amount of Neuropilin-1(NRP-1) in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary Cotinine level

  The total amount of , Cotinine in saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (5)

• Periodontal Probing Depth

  Day 1 (first visit)

• Clinical Attachment Level

  Day 1 (first visit)

• Plaque Index

  Day 1 (first visit)

• Bleeding on Probing

  Day 1 (first visit)

• Gingival Index

  Day 1 (first visit)

Study Arms (4)

Healthy Periodontium

EXPERIMENTAL

Individuals with less than 10% bleeding on probing, probing depth less than 4 mm, and no attachment loss, based on evaluation in 6 areas of each tooth.

Diagnostic Test: Saliva obtaining

Gingivitis

EXPERIMENTAL

Individuals who, in the evaluation made in 6 areas of each tooth, had bleeding on probing in more than 10% of the areas, had a probing depth of less than 4 mm and had no attachment loss.

Diagnostic Test: Saliva obtaining

non-smoker periodontitis

EXPERIMENTAL

Individuals who have bleeding on probing in 30% or more of the area, who have a probing pocket depth of 5 mm or more in at least 2 non-adjacent teeth in each quadrant of the jaw, who have attachment loss of 4 mm or more, and who have coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs.

Diagnostic Test: Saliva obtaining

smoker periodontitis

EXPERIMENTAL

Individuals who smoke at least 10 cigarettes per day, have bleeding on probing in 30% or more of the area, have a probing pocket depth of 5 mm or more in at least 2 non-adjacent teeth in each quadrant of the jaw, have attachment loss of 4 mm or more, and have coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs.

Diagnostic Test: Saliva obtaining

Interventions

Saliva obtaining DIAGNOSTIC_TEST

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.

Gingivitis; Healthy Periodontium; non-smoker periodontitis; smoker periodontitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy (Determination of volunteers will be based on patient statements in the anamnesis. No additional examination will be performed.)
• At least 16 permanent teeth in the mouth
• For non-smoking groups: never smoked
• For the smoking group: smoking at least 10 cigarettes per day
• No continuously used medications
• No use of antibiotics, anti-inflammatory drugs, and systemic corticosteroids in the last 6 months
• Not pregnant or breastfeeding
• No periodontal treatment in the last 6 months
• For the Periodontitis group: based on the evaluation of 6 sites per tooth, ≥30% bleeding on probing, probing depth ≥5 mm and clinical attachment loss ≥4 mm in at least 2 non-adjacent teeth in a quadrant, and radiographic bone loss of coronal 1/3 or more (horizontal and/or vertical)
• For the Gingivitis group: based on the evaluation of 6 sites per tooth, ≥10% bleeding on probing, probing depth \<4 mm, and no clinical attachment loss
• For the Healthy group: based on the evaluation of 6 sites per tooth, \<10% bleeding on probing, probing depth \<4 mm, and no clinical attachment loss

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis; Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Behavior

Study Officials

• Abdullah Seçkin Ertuğrul, Prof. Dr.

  Izmir Katip Çelebi University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant at Periodontology

Model Details: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20) and with 20 systemically healthy smoker individuals with periodontitis (PS, n=20).

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: May 10, 2024
• Primary Completion: November 25, 2024
• Study Completion: March 20, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)