Actively Recruiting

Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID06961409

Evaluation of Salivary Granulocyte-Macrophage Colony-Stimulating Factor, Macrophage Inflammatory Protein and Interleukin-1β Levels in Individuals With Different Periodontal Conditions

Led by Izmir Katip Celebi University · Updated on 2025-05-07

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the role of specific proteins called cytokines in chronic inflammatory diseases affecting the mouth, specifically focusing on periodontal diseases like gingivitis and periodontitis. This study aims to measure the levels of three cytokines—Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Macrophage Inflammatory Protein (MIP)-1α, and Interleukin (IL)-1β—in the saliva of healthy individuals and those with gingivitis or periodontitis. Understanding these levels may help reveal how these proteins contribute to inflammation and disease progression. The study involves 60 systemically healthy adults, divided into three groups: healthy, gingivitis, and periodontitis, each consisting of 20 participants. Full-mouth clinical periodontal measurements will be recorded, and saliva samples will be collected by having participants sit upright and tilt their head forward to allow saliva to accumulate. The saliva samples will be processed and stored at -80ºC until analysis. The cytokine levels will be determined using an enzyme-linked immunoassay (ELISA) technique. Participants will undergo initial clinical evaluations including bleeding on probing, probing depth, attachment level, plaque index, and gingival index measurements. Saliva will be collected 24 hours after clinical measurements to assess cytokine levels. Statistical analyses will compare cytokine amounts between groups and examine their relationship with clinical parameters. The study may help identify these cytokines as diagnostic markers or potential targets for future periodontal disease treatments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Systemically healthy participants
  • At least twenty permanent teeth present in the mouth
  • Non-smokers
  • No continuous medication use
  • Not pregnant or breastfeeding
Not Eligible

You will not qualify if you...

  • 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 corticosteroids in the last 6 months
  • Smokers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo full-mouth clinical periodontal measurements and saliva samples are collected to assess levels of GM-CSF, MIP-1α, and IL-1β.

1 visit (in-person) for clinical measurements and saliva collection

Long-term Monitoring

Duration - Up to study completion in October 2025

Participants are observed to evaluate salivary biomarker levels related to periodontal conditions without receiving active treatment.

No additional visits; observation only

Trial Site Locations

Total: 1 location

1

Izmir Katip Çelebi University Department of Periodontology

Izmir, Çiğli, Turkey (Türkiye), 35640

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Research Team

M

Mehmet Sait Bilgiç, Research assistant

Ş

Şükrü Enhoş, Prof. Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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