Evaluation of Salivary Biomarker Levels in Individuals With Different Periodontal Conditions

NCT06558136 | Completed

• 1 other identifier: 2024--SAEK-0040
• 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. Recent publications have investigated the role of Interleukin-6 (IL-6), Interleukin-8 (IL-8) and LIGHT in chronic inflammatory diseases. The aim of this study was to evaluate the levels of these cytokines in the saliva of healthy individuals with gingivitis and periodontitis and to investigate whether they are reliable biomarkers for the diagnosis of periodontitis. In the current study, all oral clinical parameters of 60 systemically healthy individuals (20 healthy, 20 with gingivitis and 20 with periodontitis) who were admitted to the clinic for routine periodontal control will be measured and saliva samples will be taken from the patients. IL-6, IL-8 and LIGHT (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 between 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

Periodontitis; Gingivitis; Periodontal Health

Keywords

periodontitis; gingivitis; periodontal health; IL-6; IL-8; LIGHT; salivary level

Outcome Measures

Primary Outcomes (3)

• Salivary LIGHT level

  Total amount of LIGHT protein in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary IL-6 level

  total amount of interleukin-6 in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary IL-8 level

  Total amount of interleukin-8 in saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (5)

• Periodontal Probing Depth

  during the the initial visit

• Clinical Attachment Level

  during the the initial visit

• Plaque Index

  during the the initial visit

• Gingival Index

  during the the initial visit

• Bleeding on probing

  during the 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.

Gingivitis; Healthy Periodontium; Periodontitis

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

Adult individuals aged 18 to 70 years, including periodontally healthy subjects, patients with gingivitis, and patients with periodontitis, recruited from patients presenting for routine dental examinations at the Department of Periodontology, İzmir Katip Çelebi University

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, İzmir, 35640, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated saliva samples collected for biomarker analysis (without DNA extraction) will be retained.

MeSH Terms

Conditions

Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Officials

• Şükrü Enhoş

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

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: August 1, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)