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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06427902
Other study ID # Depression
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2018
Est. completion date September 16, 2019

Study information

Verified date May 2024
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date September 16, 2019
Est. primary completion date June 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 53 Years
Eligibility 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

Study Design


Intervention

Other:
Periodontal clinical measurements, Saliva sampling
Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque

Locations

Country Name City State
Turkey Duygu Ilhan Istanbul Select State

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary SalivaryTREM-1 Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA. 06-09 2019
Primary Salivary PGLYRP1 Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA. 06-09 2019
Primary Salivary IL-1ß Both, soluble and membrane-bound IL-1ß detected by the IL-1ß ELISA. 06-09 2019
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