CClinicalTrials.gg
CompletedNCT06427902Updated May 24, 2024

Inflammatory Biomarkers in Saliva at Depression

An observational study in Gingivitis, Depression and Inflammation, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 53 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Medipol University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
65
Ages
18 Years to 53 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Gingivitis
  • Depression
  • Inflammation
  • Inflammatory Response
03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 65 is below the median of 90 across 104 observational studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 53 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
65 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Other: Periodontal clinical measurements, Saliva sampling

  • 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.

    Other: Periodontal clinical measurements, Saliva sampling

  • systemically and periodontally healthy (SPH) individuals

    This group contists of individuals who are systemically and periodontally healthy

    Other: Periodontal clinical measurements, Saliva sampling

Interventions

  • OtherPeriodontal clinical measurements, Saliva sampling

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

06

What researchers measure

Primary outcomes

  1. SalivaryTREM-1

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

    Time frame: 06-09 2019

  2. Salivary PGLYRP1

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

    Time frame: 06-09 2019

  3. Salivary IL-1β

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

    Time frame: 06-09 2019

07

Study locations

1 site
  • Duygu Ilhan
    Istanbul, Select State 34365, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06427902
Lead sponsor
Medipol University
Responsible party
DUYGU ILHAN (Asst. Prof, Medipol University) — Principal investigator
First posted
May 24, 2024
Start date
Dec 10, 2018
Primary completion
Jun 14, 2019
Completion
Sep 16, 2019
Last update
May 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion