Periodontal DiseasesNCT05924828
sTREM-1, sTREM-2, Presepsin, and Periodontitis
An observational study of Periodontal Diseases and Periodontitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio of participants with/without periodontitis. The main question it aims to answer is there a relationship between saliva sTREM-1, sTREM-2, Presepsin levels, sTREM-1/sTREM-2 ratio and periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Periodontitis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Dec 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals who referred to Atatürk University, Department of Periodontology
Who may be able to join
- Individuals should not have any systemic disease that may or may not require medication, including salivary gland pathologies, and not particularly thyroid organ pathologies.
- Individuals have not been continuously treated with anti-inflammatory, antioxidant or similar drugs in the last 6 months,
- Individuals have not received periodontal treatment until 6 months ago,
- Individuals must have at least 14 teeth
- Patients diagnosed with stage 3 periodontitis
Who cannot join
- Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
- Being pregnant/breastfeeding
- Being on medication for any reason
- Being a smoker/tobacco user
- Having another periodontal disease other than periodontitis
- Having a chronic inflammatory disease (COPD, asthma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of sTREM-1, sTREM-2, Presepsin, and Its Association With Periodontitis: A Randomized Controlled Three-Blinded Clinic Study
The goal of this observational study is to compare saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio of participants with/without periodontitis.
The main question it aims to answer is there a relationship between saliva sTREM-1, sTREM-2, Presepsin levels, sTREM-1/sTREM-2 ratio and periodontitis.
Participants will give saliva samples without any intervention
Read the detailed description
Periodontitis is a chronic, inflammatory disease with a cyclical course with active and passive periods, which may result in the destruction of gingival fibers, resorption of alveolar bone, and subsequent tooth loss, by spreading the inflammatory event that started in the gingiva to the tissues supporting the tooth as a result of the effects of bacteria. The disease is closely associated with many systemic conditions. These conditions include diabetes, cardiovascular diseases, respiratory diseases, birth complications, pregnancy, puberty.
sTREM-1, the soluble form of TREM-1 resulting from the cleavage by MMP (matrix metalloproteinase) of the extracellular portion of this receptor, was identified in 2004. Higher concentrations of sTREM-1 were noted in gingival crevicular fluid (GCF) and saliva from patients with periodontitis and correlated with certain periodontal clinical parameters (Plaque Index [PlI], Gingival Index [GI], PPD or clinical attachment loss [CAL]). TREM-2, another member of the TREM family, is also synthesised by macrophages and together with its receptor, DNAX-activating protein of 12 kDa (DAP12), functions to suppress the proinflammatory response. Initial studies with TREM-2 in microglia cells showed that it plays an important role in suppressing TNF-α and IL-6 levels. The secretion of presepsin has been reported as a stimulus of monocytes phagocytosis. Therefore, recognition of presepsin is predictable even in healthy non-infective individuals. The concept for presepsin proposes that its levels should be measureable in non-infective individuals, increase the early steps of bacterial infections, and its levels should be dependent on the intensity of the innate immune induction.
The study material will be 70 adult individuals who applied to Atatürk University Faculty of Dentistry, Department of Periodontology for different reasons {1. group (H): periodontally healthy individuals, group 2 (P): individuals with periodontitis}. Saliva samples will be collected from the participants without any periodontal intervention. sTREM-1, sTREM-2, Presepsin levels will be studied.
The aim of this study; to evaluate the saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio in the saliva samples of patients with periodontitis by comparing them with healthy controls, and to investigate the association in the pathogenesis of periodontitis or a simple marker of disease activity in the light of these findings.
- Conditions
- Periodontal Diseases, Periodontitis
- Being tested
- no intervention
- Keywords
- periodontitis, sTREM-1, sTREM-2, Presepsin
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called periodontitis, healthy
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy | participants without periodontitis Receives: Other: no intervention | |
| periodontitis | participants with stage-3 periodontitis Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sTREM-1, sTREM-2, Presepsin
sTREM-1, sTREM-2, Presepsin levels in saliva
Measured: 0-1 hours of the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- DİDEM ÖZKAL EMİNOĞLU, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924828
- Sponsor's protocol ID
- atauniperio3
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of sTREM-1, sTREM-2, Presepsin, and Its Association With Periodontitis: A Randomized Controlled Three-Blinded Clinic Study
- ClinicalTrials.gov ID
- NCT05924828
- Acronym / sponsor ID
- atauniperio3
- Conditions
- Periodontal Diseases, Periodontitis
- Keywords
- periodontitis, sTREM-1, sTREM-2, Presepsin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 29 Jun 2023 (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 compare saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio of participants with/without periodontitis.
The main question it aims to answer is there a relationship between saliva sTREM-1, sTREM-2, Presepsin levels, sTREM-1/sTREM-2 ratio and periodontitis.
Participants will give saliva samples without any intervention
Detailed description
Periodontitis is a chronic, inflammatory disease with a cyclical course with active and passive periods, which may result in the destruction of gingival fibers, resorption of alveolar bone, and subsequent tooth loss, by spreading the inflammatory event that started in the gingiva to the tissues supporting the tooth as a result of the effects of bacteria. The disease is closely associated with many systemic conditions. These conditions include diabetes, cardiovascular diseases, respiratory diseases, birth complications, pregnancy, puberty.
sTREM-1, the soluble form of TREM-1 resulting from the cleavage by MMP (matrix metalloproteinase) of the extracellular portion of this receptor, was identified in 2004. Higher concentrations of sTREM-1 were noted in gingival crevicular fluid (GCF) and saliva from patients with periodontitis and correlated with certain periodontal clinical parameters (Plaque Index [PlI], Gingival Index [GI], PPD or clinical attachment loss [CAL]). TREM-2, another member of the TREM family, is also synthesised by macrophages and together with its receptor, DNAX-activating protein of 12 kDa (DAP12), functions to suppress the proinflammatory response. Initial studies with TREM-2 in microglia cells showed that it plays an important role in suppressing TNF-α and IL-6 levels. The secretion of presepsin has been reported as a stimulus of monocytes phagocytosis. Therefore, recognition of presepsin is predictable even in healthy non-infective individuals. The concept for presepsin proposes that its levels should be measureable in non-infective individuals, increase the early steps of bacterial infections, and its levels should be dependent on the intensity of the innate immune induction.
The study material will be 70 adult individuals who applied to Atatürk University Faculty of Dentistry, Department of Periodontology for different reasons {1. group (H): periodontally healthy individuals, group 2 (P): individuals with periodontitis}. Saliva samples will be collected from the participants without any periodontal intervention. sTREM-1, sTREM-2, Presepsin levels will be studied.
The aim of this study; to evaluate the saliva sTREM-1, sTREM-2, Presepsin levels and sTREM-1/sTREM-2 ratio in the saliva samples of patients with periodontitis by comparing them with healthy controls, and to investigate the association in the pathogenesis of periodontitis or a simple marker of disease activity in the light of these findings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: no interventionparticipants without periodontitis |
| periodontitis | – | Other: no interventionparticipants with stage-3 periodontitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals who referred to Atatürk University, Department of Periodontology
Key inclusion criteria (5 listed)
- Individuals should not have any systemic disease that may or may not require medication, including salivary gland pathologies, and not particularly thyroid organ pathologies.
- Individuals have not been continuously treated with anti-inflammatory, antioxidant or similar drugs in the last 6 months,
- Individuals have not received periodontal treatment until 6 months ago,
- Individuals must have at least 14 teeth
- Patients diagnosed with stage 3 periodontitis
Key exclusion criteria (6 listed)
- Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
- Being pregnant/breastfeeding
- Being on medication for any reason
- Being a smoker/tobacco user
- Having another periodontal disease other than periodontitis
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 |
|---|---|---|
| no interventionAlso: periodontitis, healthyno intervention | Other | Healthy, periodontitis |
Primary outcome
sTREM-1, sTREM-2, Presepsin
Time frame: 0-1 hours of the diagnosis
sTREM-1, sTREM-2, Presepsin levels in saliva
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 30 Jan 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.
DİDEM ÖZKAL EMİNOĞLU study director
Ataturk University
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 Periodontal Diseases and Periodontitis, run by Ataturk 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 5 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 30 Jan 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?
sTREM-1, sTREM-2, Presepsin (time frame: 0-1 hours of the diagnosis). 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 30 Jan 2024.