Clinical trial NCT07025291: Assessment of Salivary Biomarker Levels in Individuals With Various Periodontal Diseases
Official title: Evaluation of Salivary Hypoxia-Inducible Factor -2 Alpha, Matrix Metalloproteinase-9 and Tartrate-Resistant Acid Phosphatase-5b Levels in Individuals With Different Periodontal Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Keywords: periodontitis
gingivitis
saliva
HIF-2a
TRAP-5b
MMP-9
ELISA
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Salivary HIF-2α levels
timeFrame: 24 hours after taking the clinical measurements at the first visit
measure: Salivary TRAP-5b levels
timeFrame: 24 hours after taking the clinical measurements at the first visit
measure: Salivary MMP-9 levels
timeFrame: 24 hours after taking the clinical measurements at the first visit
Secondary outcomes:
measure: probing depth
timeFrame: During the first 1 day visit
measure: clinical attachment level
timeFrame: During the first 1 day visit
measure: plaque index
timeFrame: During the first 1 day visit
measure: gingival index
timeFrame: During the first 1 day visit
measure: bleeding on probing
timeFrame: During the first 1 day visit
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University Faculty of Dentistry
state: Cigli
Study officials:
References: