Assessment of Salivary Biomarker Levels in Individuals With Various Periodontal Diseases

NCT07025291 | Completed

• 1 other identifier: 2024-SAEK-0421
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Keywords

periodontitis; gingivitis; saliva; HIF-2a; TRAP-5b; MMP-9; ELISA

Outcome Measures

Primary Outcomes (3)

• Salivary HIF-2α levels

  the total amount of HIF-2α in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary TRAP-5b levels

  the total amount of TRAP-5b in saliva

  24 hours after taking the clinical measurements at the first visit

• Salivary MMP-9 levels

  the total amount of MMP-9 in saliva

  24 hours after taking the clinical measurements at the first visit

Secondary Outcomes (5)

• probing depth

  During the first 1 day visit

• clinical attachment level

  During the first 1 day visit

• plaque index

  During the first 1 day visit

• gingival index

  During the first 1 day visit

• bleeding on probing

  During the first 1 day visit

Study Arms (3)

healthy periodontium

EXPERIMENTAL

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.

Diagnostic Test: saliva obtaining

Gingivitis

EXPERIMENTAL

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.

Diagnostic Test: saliva obtaining

periodontitis

EXPERIMENTAL

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.

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 salivav 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+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University Faculty of Dentistry

Izmir, Cigli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis; Erythrocytosis, Familial, 4

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: According to full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL),bleeding on probing (BOP), gingival index (GI) and plaque index (PI) samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20).

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 17, 2025
• Study Start: January 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: November 1, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)