- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427902
Inflammatory Biomarkers in Saliva at Depression
Salivary Biomarkers of Gingival Inflammation Are Associated With Depression
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?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Select State
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Istanbul, Select State, Turkey, 34365
- Duygu Ilhan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
depression with gingivitis (DG) group
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. |
Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque
|
|
depression with periodontally healthy (DPH) patients
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.
|
Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque
|
|
systemically and periodontally healthy (SPH) individuals
This group contists of individuals who are systemically and periodontally healthy
|
Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SalivaryTREM-1
Time Frame: 06-09 2019
|
Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.
|
06-09 2019
|
|
Salivary PGLYRP1
Time Frame: 06-09 2019
|
Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.
|
06-09 2019
|
|
Salivary IL-1β
Time Frame: 06-09 2019
|
Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.
|
06-09 2019
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Depression (Other Identifier: PILL)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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