GCF Levels of IL-1Beta, MIP-1 Alfa and G-CSF in Gingivitis and Stage I-II-III-IV Periodontitis Patients

Sponsor
Uşak University (Other)
Overall Status
Completed
CT.gov ID
NCT04629313
Collaborator
(none)
120
1
4
30.2

Study Details

Study Description

Brief Summary

Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gums that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gum along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta, MIP-1alfa and G-CSF are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta, MIP-1alfa, G-CSF cytokines in the gum groove fluid of periodontal healthy and diseased individuals.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were used After clinical evaluation, individuals were divided into 6 groups Healthy control groups, gingivitis groups, Stage I groups, Stage II groups, Stage III groups and Stage IV groups GCF samples were collected after clinical periodontal measurement. GCF was obtained using strips of filter paper Kolmogorov-Smirnov and Shapiro Wilk's tests used

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Usak University Faculty of Dentistry
    Actual Study Start Date :
    Jul 1, 2020
    Actual Primary Completion Date :
    Oct 30, 2020
    Actual Study Completion Date :
    Oct 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    periodontal disease group

    Gingivitis: BOP score of 10% or greater and PD≤3mm with no attachment or radiographic bone loss. SI Periodontitis: interdental AL of 1-2 mm, PD≤4 mm and no tooth loss SII Periodontitis: interdental AL of 3-4 mm, PD≤5 mm and no tooth loss SIII Periodontitis: interdental AL ≥5 mm, PD≥6 mm SIV Periodontitis: interdental AL ≥5 mm teeth, radiographic bone lose extending to middle or apical third of the root,

    periodontal healthy group

    consisted of individuals with clinically healthy gingiva

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of IL-1Beta, G-CSF, MIP-1alfa levels in GCF [GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement. GCF was obtained using strips of filter paper† from the buccal part of an interproximal region.]

      Measurement of GCF samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Clinical diagnosis of periodontal diseases

    • Individuals must have 16 permanent teeth in their mouth

    Exclusion Criteria:
    • Diabetes

    • İmmunological diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Usak Uşak Turkey 64200

    Sponsors and Collaborators

    • Uşak University

    Investigators

    • Principal Investigator: ahu dikilitaş, University of Usak
    • Study Chair: fatih karaaslan, University of Usak
    • Study Chair: umut yiğit, University of Usak
    • Study Chair: esra özge aydın, University of Usak
    • Study Director: Abdullah seçkin ertuğrul, University of Usak

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahu Dikilitaş, Principal investigator, Uşak University
    ClinicalTrials.gov Identifier:
    NCT04629313
    Other Study ID Numbers:
    • UsakU6
    First Posted:
    Nov 16, 2020
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahu Dikilitaş, Principal investigator, Uşak University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021