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

Sponsor
Ataturk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05924828
Collaborator
(none)
70
1
4
17.5

Study Details

Study Description

Brief 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.

Participants will give saliva samples without any intervention

Condition or Disease Intervention/Treatment Phase
  • Other: no 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

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Comparison of sTREM-1, sTREM-2, Presepsin, and Its Association With Periodontitis: A Randomized Controlled Three-Blinded Clinic Study
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. sTREM-1, sTREM-2, Presepsin [0-1 hours of the diagnosis]

      sTREM-1, sTREM-2, Presepsin levels in saliva

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atatürk University Erzurum Turkey 25240_

    Sponsors and Collaborators

    • Ataturk University

    Investigators

    • Study Director: DİDEM ÖZKAL EMİNOĞLU, Atatürk University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Didem OZKAL EMINOGLU, assistant professor, Ataturk University
    ClinicalTrials.gov Identifier:
    NCT05924828
    Other Study ID Numbers:
    • atauniperio3
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jun 29, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Didem OZKAL EMINOGLU, assistant professor, Ataturk University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 29, 2023