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

NCT ID: NCT06561971

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-01-22

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Non-Smokers

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Group Type: EXPERIMENTAL

saliva obtaining

Intervention Type: 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.

Light Smokers

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Group Type: EXPERIMENTAL

saliva obtaining

Intervention Type: 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

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Group Type: EXPERIMENTAL

saliva obtaining

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

Ece Ozer

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ece Özer

Role: CONTACT

Phone: +90 5306958625

Email: ozerrece@gmail.com

Mehmet Sağlam

Role: CONTACT

Facility Contacts

Ece Özer

Role: primary

Other Identifiers

2024-SAEK-0029

Identifier Type: -

Identifier Source: org_study_id