GingivitisNCT06427902
Inflammatory Biomarkers in Saliva at Depression
An observational study of Gingivitis and Depression, run by Medipol University at 1 site in Turkey (Türkiye).
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? Read more about this study
- Who is it for?
- Ages 18 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Depression, Inflammation
- What is being tested?
- Periodontal clinical measurements, Saliva sampling
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 16 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 53 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- psychotic disorders
- autism spectrum disorders
- other anxiety disorders
- bipolar disorder
- mental any organic mental disorder and
- smokers, substance users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
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.
- Conditions
- Gingivitis, Depression, Inflammation, Inflammatory Response
- Being tested
- Periodontal clinical measurements, Saliva sampling
- Medical subject headings
- Gingivitis, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical measurements, Saliva samplingOther
Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Periodontal clinical measurements, Saliva sampling | |
| systemically and periodontally healthy (SPH) individuals | This group contists of individuals who are systemically and periodontally healthy Receives: Other: Periodontal clinical measurements, Saliva sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
SalivaryTREM-1
Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.
Measured: 06-09 2019
Salivary PGLYRP1
Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.
Measured: 06-09 2019
Salivary IL-1β
Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.
Measured: 06-09 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start10 Dec 2018
- Primary completion14 Jun 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU ILHAN, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427902
- Sponsor's protocol ID
- Depression
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Biomarkers of Gingival Inflammation Are Associated With Depression
- ClinicalTrials.gov ID
- NCT06427902
- Acronym / sponsor ID
- Depression
- Conditions
- Gingivitis, Depression, Inflammation, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| depression with gingivitis (DG) group | – | Other: Periodontal clinical measurements, Saliva samplingThe 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. |
| depression with periodontally healthy (DPH) patients | – | Other: Periodontal clinical measurements, Saliva samplingThe 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. |
| systemically and periodontally healthy (SPH) individuals | – | Other: Periodontal clinical measurements, Saliva samplingThis group contists of individuals who are systemically and periodontally healthy |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- psychotic disorders
- autism spectrum disorders
- other anxiety disorders
- bipolar disorder
- mental any organic mental disorder and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal clinical measurements, Saliva samplingClinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque | Other | depression with gingivitis (DG) group, depression with periodontally healthy (DPH) patients, systemically and periodontally healthy (SPH) individuals |
Primary outcome
SalivaryTREM-1
Time frame: 06-09 2019
Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA.
Salivary PGLYRP1
Time frame: 06-09 2019
Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA.
Salivary IL-1β
Time frame: 06-09 2019
Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Depression, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SalivaryTREM-1 (time frame: 06-09 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.