Determination of Salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible Factor-1 Alpha (HIF-1α), E-cadherin, Galectin 3, IL-4, IL-10 and TNF-α Levels in Individuals With Different Degrees of Periodontal Disease

NCT06430450 | Not Yet Recruiting DMC

• 1 other identifier: ISMAILKMU
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this clinical study is; Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees and to evaluate and analyze correlations with clinical parameters. In our study, saliva samples will be taken from a total of 80 systemically healthy volunteers, 20 of patients are periodontal healthy, 20 of patients have degree A periodontitis, 20 of patients have degree B periodontitis and 20 of patients have degree C periodontitis, along with the measurement of whole mouth clinical parameters. Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in the samples taken will be subjected to enzyme-related immunoassay ( It will be determined by ELISA). Cytokine levels between different groups will then be interpreted as a result of statistical analysis. Possible significant differences shed light on future studies with Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α. These cytokines may help develop different diagnostic methods or treatment strategies in future periodontal treatments.

Conditions

Periodontitis; Periodontal Diseases

Keywords

Periodontitis; Saliva; Cytokine

Outcome Measures

Primary Outcomes (1)

• Outcome 1

  Comparatively comparing salivary Soluble Urokinase Plasminogen Activator Receptor (SuPAR), Hypoxia-inducible factor-1 alpha (HIF-1α), E-cadherin, galectin 3, IL-4, IL-10 and TNF-α levels in individuals with different Periodontal Disease Degrees. To examine and determine the correlation of these cytokines with clinical measurements.

  First 5 months

Secondary Outcomes (1)

• Outcome 2

  Two months after the study was completed

Study Arms (4)

Healty

Individuals who have no clinical signs of inflammation in the periodontal tissues and the number of areas showing bleeding on probing does not exceed 20%.

Diagnostic Test: Clinical measurements and saliva samples collection

Grade A

Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and radiological bone loss percentage/age ratio in the tooth with the most bone loss \<0.25

Diagnostic Test: Clinical measurements and saliva samples collection

Grade B

Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant jaw, attachment loss, and a radiological bone loss percentage/age ratio of 0.25-1.0 in the tooth with the most bone loss.

Diagnostic Test: Clinical measurements and saliva samples collection

Grade C

Individuals with a probing pocket depth of 5 mm or more in at least 2 teeth in each quadrant of the jaw, attachment loss, and a radiological bone loss percentage/age ratio \>1.0 in the tooth with the most bone loss.

Diagnostic Test: Clinical measurements and saliva samples collection

Interventions

Clinical measurements and saliva samples collection DIAGNOSTIC_TEST

Clinical measurements will be taken from all patients and saliva samples will be collected for biochemical analysis.

Grade A; Grade B; Grade C; Healty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 20 healty patients * 20 Grade A periodontitis * 20 Grade B periodontitis * 20 Grade C periodontitis

You may qualify if:

• Patients with a varying degree of periodontal status (periodontally healthy, gingivitis, and chronic periodontitis).
• Have no systemic disease.
• No smoking/ not using any tobacco products or alcohol.
• No periodontal therapy in last 6 months.
• Not using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
• Not to be pregnant or in lactation period.
• Having ≥20 permanent teeth.

You may not qualify if:

• Having any systemic disease.
• Smokers, other tobacco product, and alcohol consumers.
• Having any periodontal therapy in last 6 months.
• Using any anti-inflammatory drugs in last 3 months and antibiotics in last 6 months.
• Being pregnant or in lactation period.
• Having ˂20 permanent teeth.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Related Publications (1)

• Tasdemir I, Ozgoren O, Yilmaz HE, Kartal E, Altunyaprak S, Saglam M. Salivary levels of suPAR, HIF-1alpha and TNF-alpha in different grades of stage III periodontitis. BMC Oral Health. 2025 May 22;25(1):760. doi: 10.1186/s12903-025-06155-3.

  PMID: 40405145 DERIVED

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

ismail taşdemir, assistant professor

CONTACT

+905455694573; drismailtasdemir@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: July 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: January 15, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share