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

NCT06561971 | Recruiting

• 1 other identifier: 2024-SAEK-0029
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• The total amount of hs-CRP in saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (1)

• Determining the ideal centrifugal value range of hs-CRP saliva level

  Within 1 week after receiving the biochemical analysis results

Study Arms (3)

Non-Smokers

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: saliva obtaining

Light Smokers

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: saliva obtaining

Heavy Smokers

EXPERIMENTAL

Full-mouth clinical periodontal measurements recorded and saliva obtained.

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.

Heavy Smokers; Light Smokers; Non-Smokers

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• Individual with periodontal disease

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Ece Özer

CONTACT

+90 5306958625; ozerrece@gmail.com

Mehmet Sağlam

CONTACT

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

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 90 systemically healthy non-smoker individuals with heavy smokers (H, n=30), light smokers(L, n=30) and non-smokers (N, n=30).

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 22, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)