## Protocol Section
### Identification Module
**NCT ID:** NCT06427902

**Brief Title:** Inflammatory Biomarkers in Saliva at Depression

**Official Title:** Salivary Biomarkers of Gingival Inflammation Are Associated With Depression

#### Organization Study ID Info
**ID:** Depression
#### Organization
**Class:** OTHER
**Full Name:** Medipol University
### Status Module
#### Completion Date
**Date:** 2019-09-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06-14

**Type:** ACTUAL

#### Start Date
**Date:** 2018-12-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medipol University

#### Responsible Party

**Investigator Affiliation:** Medipol University

**Investigator Full Name:** DUYGU ILHAN

**Investigator Title:** Asst. Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The goal of this observational study is to evaluate the inflammatory saliva biomarkers in depression and gingivitis.

The main question will be ; Will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis?

**Detailed Description:** Background: The neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. The present study was to evaluate the periodontal health status and the levels of Triggering receptor expressed on myeloid cells 1 (TREM-1), peptidoglycan recognition protein 1 (PGLYRP1) and interleukin-1 beta (IL-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals.

Methods: Forty-two depression patients were classified in two groups: depression with gingivitis (DG) and depression with periodontally healthy (DPH) patients. Additionally, 23 systemically and periodontally healthy (SPH) individuals were enrolled to the study. Periodontal parameters were recorded. Saliva samples were collected and salivary levels of TREM-1, PGLYRP1, IL-1β were measured using Enzyme-linked Immunosorbent Assay (ELISA) kits.

depression regardless of periodontal status.

### Conditions Module

**Conditions:**

- Gingivitis

- Depression

- Inflammation

- Inflammatory Response

### Design Module

#### Bio Spec

**Description:** Saliva

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 65

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.

the gingivitis group was determined by the criteria of pocket depth of 3 mm or less.

**Intervention Names:**

- Other: Periodontal clinical measurements, Saliva sampling

**Label:** depression with gingivitis (DG) group

#### Arm Group 2

**Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders.

**Intervention Names:**

- Other: Periodontal clinical measurements, Saliva sampling

**Label:** depression with periodontally healthy (DPH) patients

#### Arm Group 3

**Description:** This group contists of individuals who are systemically and periodontally healthy

**Intervention Names:**

- Other: Periodontal clinical measurements, Saliva sampling

**Label:** systemically and periodontally healthy (SPH) individuals

### Interventions

#### Intervention 1

**Arm Group Labels:**

- depression with gingivitis (DG) group

- depression with periodontally healthy (DPH) patients

- systemically and periodontally healthy (SPH) individuals

**Description:** Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque

**Name:** Periodontal clinical measurements, Saliva sampling

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.

**Measure:** SalivaryTREM-1

**Time Frame:** 06-09 2019

**Description:** Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.

**Measure:** Salivary PGLYRP1

**Time Frame:** 06-09 2019

**Description:** Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.

**Measure:** Salivary IL-1β

**Time Frame:** 06-09 2019

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months

Exclusion Criteria: Patients with

* psychotic disorders
* autism spectrum disorders
* other anxiety disorders
* bipolar disorder
* mental any organic mental disorder and
* smokers, substance users

**Healthy Volunteers:** True

**Maximum Age:** 53 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** This study was carried out on 65 participants in total, including 42 individuals who applied to Aydın State Hospital Psychiatry Outpatient Clinic, diagnosed with depressive disorder, were classified in 2 different groups; depression with gingivitis (DG), depression with periodontally healthy (DPH) patients and 23 systemically and periodontally healthy (SPH) individuals who applied to Adnan Menderes University Faculty of Dentistry.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Duygu Ilhan

**State:** Select State

**Zip:** 34365

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007239

- Term: Infections

- ID: D000005882

- Term: Gingival Diseases

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M9003

- Name: Gingivitis

- Relevance: HIGH

- As Found: Gingivitis

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8994

- Name: Gingival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005891

- Term: Gingivitis

- ID: D000007249

- Term: Inflammation

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-31
