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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04629313
Other study ID # UsakU6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date October 30, 2020

Study information

Verified date September 2021
Source Usak University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of periodontal diseases - Individuals must have 16 permanent teeth in their mouth Exclusion Criteria: - Diabetes - Immunological diseases

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey University of Usak Usak

Sponsors (1)

Lead Sponsor Collaborator
Usak University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of IL-1Beta, G-CSF, MIP-1alfa levels in GCF Measurement of GCF samples 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.
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