Assessment of Salivary Biomarker Levels in Individuals With Various Periodontal Diseases

Izmir Katip Celebi University

Status: Enrolling

Conditions: Periodontal Diseases

Treatments: Diagnostic Test: saliva obtaining

Study type: Interventional

Funder types: Other

Identifiers

NCT07025291

2024-SAEK-0421

Details and patient eligibility

About

The aim of this study is to compare the salivary levels of HIF-2 alpha, MMP-9, and TRAP-5b among healthy individuals, patients with gingivitis, and patients with periodontitis; to examine the relationship between these levels and clinical parameters; and to determine their effectiveness in distinguishing periodontal disease from a healthy condition. It will be evaluated whether these biochemical mediators can be used as diagnostic biomarkers in the diagnosis of periodontal disease.

Periodontal health is defined as the absence of signs of inflammation. Gingivitis is an inflammation of the gums and, if left untreated, can progress to periodontitis, a more severe condition characterized by the destruction of the supporting structures of the teeth. In this destruction, the host immune response to bacterial products and various inflammatory mediators (cytokines, MMPs) play a role.

MMP-9 plays a significant role in the progression of inflammation and tissue damage. HIF-2 alpha is a factor that regulates bone formation and resorption and is activated in hypoxic or inflammatory environments. TRAP-5b is a specific marker of osteoclast activity and bone resorption. In the literature, there is no study that evaluates these three biomarkers together in saliva samples in the context of periodontal disease.

This study aims to investigate the changes in these salivary biomarkers in the presence of periodontal disease, their diagnostic potential, and their relationship with clinical parameters. The findings may also provide insights for future treatments targeting these cytokine pathways.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Systemically healthy (The identification of healthy volunteers will be based on patients' self-reported medical history; no additional diagnostic tests will be conducted.)
• Having at least twenty permanent teeth in the mouth
• Non-smoker
• Not on any continuous medication
• No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
• Not pregnant or lactating
• No periodontal treatment within the last 6 months
• Willing to participate in the study and having signed the "Informed Consent Form"
• Between 18 and 70 years of age

Exclusion criteria

• Having any oral or systemic disease
• Being on regular systemic medication
• Being pregnant or in the lactation period
• Having received periodontal treatment within the last 6 months
• Having used antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months
• Smoking
• Being under 18 years of age

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

healthy periodontium

Experimental group

Description:

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in less than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.

Treatment:

Diagnostic Test: saliva obtaining

Gingivitis

Experimental group

Description:

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in more than 10% of the area, had a probing depth of less than 4 mm and had no attachment loss will be included in the study.

Treatment:

Diagnostic Test: saliva obtaining

periodontitis

Experimental group

Description:

According to the evaluation made in 6 areas of each tooth, 20 individuals who showed bleeding on probing in 30% or more areas, who had a probing pocket depth of 5 mm or more and attachment loss of 4 mm or more in at least 2 non-adjacent teeth in each quadrant jaw, and who had coronal 1/3 or more (horizontal and/or vertical) bone loss on radiographs will be included in the study.

Treatment:

Diagnostic Test: saliva obtaining