Assessment of Salivary GM-CSF, MIP, and IL-1β Levels in Subjects With Varying Periodontal Conditions

NCT06961409 | Recruiting

• 1 other identifier: 2024--SAEK-0039
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In order to determine the pathogenesis of chronic inflammatory diseases, the levels of various cytokines are examined in tissues and fluids taken from the body. In recent publications, the role of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Macrophage Inflammatory Protein (MIP)-1α and Interleukin (IL)-1β on chronic inflammatory diseases has been investigated. The aim of this study was to evaluate the levels of these cytokines in the saliva of healthy individuals with gingivitis and periodontitis. All oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who applied to our clinic for routine periodontal control will be measured and saliva samples will be taken from the patients. GM-CSF, MIP-1α and IL-1β (biomarkers emphasizing inflammation in saliva samples) will be determined by enzyme-linked immunoassay (ELISA). Then, statistical analyses will be performed to interpret the difference in cytokine levels between the groups and the relationship between these cytokines and clinical parameters. Possible significant differences in cytokine levels will reveal that these proteins and enzymes can be utilized as a diagnostic tool in periodontal diseases, to distinguish periodontal disease status from healthy, or as a guide for treatments.

Conditions

Periodontal Diseases; Periodontitis; Gingivitis; Periodontal Health

Outcome Measures

Primary Outcomes (3)

• Salivary level of GM- CSF

  Amount of GM-CSF in human saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary level of MIP-1α

  Amount of MIP-1α in human saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary level of IL-1β

  Amount of IL-1β in human saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (5)

• Bleeding on Probing

  At the initial visit.

• Periodontal Probing Depth

  At the initial visit.

• Clinical Attachment Level

  At the initial visit.

• Plaque Index

  At the initial visit.

• Gingival Index

  At the initial visit.

Study Arms (3)

Healthy Periodontium

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: Saliva obtaining

Gingivitis

Full-mouth clinical periodontal measurements recorded and saliva obtained.

Diagnostic Test: Saliva obtaining

Periodontitis

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.

Healthy Periodontium

Eligibility Criteria

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

Study Population

Systemically healthy, non-smoking adults aged 18-70 years who have not used any medication in the last 6 months, are not pregnant or in the lactation period, and present for routine periodontal examination. Participants are categorized into periodontally healthy, gingivitis, and periodontitis groups based on clinical periodontal parameters

You may qualify if:

• Systemically healthy participants.
• At least twenty permanent teeth present in the oral cavity.
• Non-smokers.
• No medication for continuous use.
• Not pregnant or breastfeeding.

You may not qualify if:

• Any oral or systemic disease.
• Regular use of systemic medications.
• Pregnancy or lactation.
• Received periodontal treatment within the last 6 months.
• Use of antibiotics, anti-inflammatory medications, or systemic corticosteroids in the last 6 months.
• Smokers.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva samples collected from healthy, gingivitis, and periodontitis subjects will be retained for biomarker analysis. No DNA extraction will be performed.

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Şükrü Enhoş, Prof. Dr.

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

  STUDY DIRECTOR

Central Study Contacts

Mehmet Sait Bilgiç, Research assistant

CONTACT

+905512810621; bilgicsait21@gmail.com

Şükrü Enhoş, Prof. Dr.

CONTACT

+905557226198; sukru.enhos@ikc.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: August 14, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available (if applicable) beginning 6 months after publication of the primary results and ending 36 months after publication.
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access to the individual participant data (IPD). Proposals should be directed to the Principal Investigator. To gain access, researchers will be required to sign a data access agreement and ensure compliance with ethical data use standards.

Locations

TU (1)