Effect of Different Centrifuge Values on Saliva High Sensitive C-Reactive Protein (Hs-CRP) Levels in Individuals With Different Smoking Amounts

Evaluating the Effect of Smoking Amount on Determining Salivary High Sensitive C-Reactive Protein(Hs-CRP) Values by Centrifuging the Saliva of the Same Individuals at Different Rpm and Time.

The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. To determine the levels in saliva samples as a result of rpm-10 min and 10 rpm 6 min centrifugations and to determine the values at which a cytokine of this molecular weight should be centrifuged and to examine the possible correlation between these values and the clinical parameters of the amount of smoking. Materials and Methods: saliva samples were collected from 90 systemically healthy individuals who were non-smokers (N, n=30), light smokers <10 cigarettes per day (L, n=30) and heavy smokers >10 cigarettes per day (H, n=20). samples were taken. Full-mouth clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI), were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine hs-CRP levels in biological samples.

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Diagnostic test: saliva obtaining

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ece Özer; Phone Number: +90 5306958625; Email: ozerrece@gmail.com
• Study Contact Backup: Name: Mehmet Sağlam

Study Locations

• Turkey
  • Çiğli
    • Izmir, Çiğli, Turkey, 35640
      • Recruiting
      • Izmir Katip Çelebi University Department of Periodontology
      • Contact: Ece Özer; Phone Number: +905306918625; Email: ozerrece@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Systemically healthy
• Periodontally clinical healthy
• At least 20 permanent teeth in the mouth
• 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.

• Not received periodontal treatment in the last 6 months

  • For the non-smoker group; person who does not smoke tobacco
  • For the light-smoker group; person who smokes less than 10 cigarettes a day
  • For heavy-smoker group; person who smokes more than 10 cigarettes a day

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
• Individual with periodontal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Smokers; Full-mouth clinical periodontal measurements recorded and saliva obtained.	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.
Experimental: Light Smokers; Full-mouth clinical periodontal measurements recorded and saliva obtained.	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.
Experimental: Heavy Smokers; Full-mouth clinical periodontal measurements recorded and saliva obtained.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The total amount of hs-CRP in saliva	24 hours after taking the clinical measurements at the first visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Determining the ideal centrifugal value range of hs-CRP saliva level	Within 1 week after receiving the biochemical analysis results

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): January 22, 2025

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2024-SAEK-0029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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