## Protocol Section
### Identification Module
**NCT ID:** NCT06430450

**Brief Title:** 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

**Official Title:** 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

#### Organization Study ID Info
**ID:** ISMAILKMU
#### Organization
**Class:** OTHER
**Full Name:** Karamanoğlu Mehmetbey University
### Status Module
#### Completion Date
**Date:** 2025-01-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karamanoğlu Mehmetbey University

#### Responsible Party

**Investigator Affiliation:** Karamanoğlu Mehmetbey University

**Investigator Full Name:** İsmail Taşdemir

**Investigator Title:** Assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed Description:** The study included patients between the ages of 18 and 70 who applied to Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry Department of Periodontology, were non-smokers, had no systemic problems, had not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 3 months, were not pregnant, had not received periodontal treatment in the last 6 months, and having at least 20 teeth in its mouth; for grade A periodontitis group; 20 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 \<0.25 in the tooth with the most bone loss; for grade B periodontitis group; 20 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; for grade C periodontitis group; 20 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 \>1.0 in the tooth with the most bone loss; For the healthy group; According to the evaluation made in 6 regions of each tooth, including 20 individuals who show bleeding on probing in less than 20% of the area, have a probing depth of less than 4 mm, and have no attachment loss. The healthy and periodontal disease group will consist of 80 patients in total.Anamnesis will be taken from individuals at the beginning of the interview, and individuals who meet the specified criteria after the anamnesis will be included in the study. After being informed about the study, an informed consent form will be obtained from the individuals.

After the anamnesis is taken, clinical periodontal evaluations will be performed on individuals who are deemed to meet the inclusion criteria. Clinically, plaque index (Sillness and Löe 1964), gingival index (Löe and Sillness 1963), pocket depth and bleeding on probing index(Ainamo\&Bay, 1975) will be recorded.

Saliva samples will be taken from individuals divided into groups for biochemical examinations. Saliva samples will be taken from each patient, first frozen at -20ºC and than stored at -28ºC until the day of analysis. Cytokine levels in the samples collected from the patients will be determined by the enzyme-related immune test "Enzyme Linked-Immuno-Sorbent Assay" (ELISA).

### Conditions Module

**Conditions:**

- Periodontitis

- Periodontal Diseases

**Keywords:**

- Periodontitis

- Saliva

- Cytokine

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 5 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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%.

**Intervention Names:**

- Diagnostic Test: Clinical measurements and saliva samples collection

**Label:** Healty

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Diagnostic Test: Clinical measurements and saliva samples collection

**Label:** Grade A

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Clinical measurements and saliva samples collection

**Label:** Grade B

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Clinical measurements and saliva samples collection

**Label:** Grade C

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Grade A

- Grade B

- Grade C

- Healty

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

**Name:** Clinical measurements and saliva samples collection

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Outcome 1

**Time Frame:** First 5 months

#### Secondary Outcomes

**Description:** By investigating the changes in these cytokine levels in the presence of periodontal disease, they can be used in disease diagnosis in the future or to provide preliminary information on possible treatments that can be performed through these cytokine pathways.

**Measure:** Outcome 2

**Time Frame:** Two months after the study was completed

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** * 20 healty patients
* 20 Grade A periodontitis
* 20 Grade B periodontitis
* 20 Grade C periodontitis

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drismailtasdemir@gmail.com

**Name:** ismail taşdemir, assistant professor

**Phone:** +905455694573

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: HIGH

- As Found: Periodontal Diseases

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxia

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000000860

- Term: Hypoxia

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13848

- Name: Plasminogen

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
