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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04689438
Other study ID # UsakU7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2020
Est. completion date December 28, 2020

Study information

Verified date November 2022
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 gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva 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 and IL-6 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 and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.


Description:

Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups 1. Healthy control groups: clinically healthy gingiva 2. Gingivitis groups: BOP score of 10% or greater and PD≤3mm 3. Periodontitis groups: AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date December 28, 2020
Est. primary completion date December 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - have periodontitis - have 16 permanent teeth Exclusion Criteria: - Systemic disease - using drugs

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
gingival crevicular fluid
GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.

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 level GCF was taken interproximal region. GCF was taken within 1 week after clinical examination
Primary Measurement of IL-6 level in GCF GCF was taken interproximal region. GCF was taken within 1 week after clinical examination
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