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Completed

NCT Number: NCT06427902

Inflammatory Biomarkers in Saliva at 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?

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Key information

Conditions

Gingivitis Behavior Behavioral Symptoms Depression Gingival Diseases Infections Inflammation Inflammatory Response Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

18 year–53 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duygu Ilhan

Istanbul, Select State, 34365, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal clinical measurements, Saliva sampling

Other

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

Primary outcomes

  1. SalivaryTREM-1

    Time frame: 06-09 2019

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

  2. Salivary PGLYRP1

    Time frame: 06-09 2019

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

  3. Salivary IL-1β

    Time frame: 06-09 2019

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

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Salivary Biomarkers of Gingival Inflammation Are Associated With Depression

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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