sTREM-1, sTREM-2, Presepsin, and Periodontitis

January 29, 2024 updated by: Didem OZKAL EMINOGLU, Ataturk University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240_
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

individuals who referred to Atatürk University, Department of Periodontology

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
participants without periodontitis
Other: no intervention
no intervention
Other Names:
  • periodontitis
  • healthy
periodontitis
participants with stage-3 periodontitis
Other: no intervention
no intervention
Other Names:
  • periodontitis
  • healthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sTREM-1, sTREM-2, Presepsin
Time Frame: 0-1 hours of the diagnosis
sTREM-1, sTREM-2, Presepsin levels in saliva
0-1 hours of the diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Study Director: DİDEM ÖZKAL EMİNOĞLU, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • atauniperio3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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