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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05217277
Other study ID # 2019-146
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 6, 2020
Est. completion date September 1, 2022

Study information

Verified date January 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aimed to be done in the planned thesis to evaluate the dental and periodontal health of patients with newly diagnosed JIA and healthy-periodontal problems with cytokines from saliva and oxidative stress markers non-invasively, and thus, to determine the markers' evaluability in terms of markers in determining the state of inflammation among individuals with and without the disease.


Description:

Periodontal diseases and inflammatory diseases such as arthritis show similar clinical pathologies such as connective tissue deterioration and bone destruction. They carry the risk of being seen together and the possibility of mutual influence. It is important whether these patients have a difference in cytokine profile from individuals who do not have the disease. In the literature, it has been determined that pro and anti-inflammatory cytokines, which are involved in the pathogenesis of periodontitis, are also involved in the pathogenesis of juvenile idiopathic arthritis (JIA). Cytokines play an undeniable role in the pathogenesis of both diseases. The cytokine profile in periodontal disease is distinctly similar to that of rheumatoid arthritis (RA). As in RA, the level of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α) increase in periodontal disease. Again, it is stated that oxidative stress assessment is an important factor in evaluating the development of the disease. Saliva evaluation can be made with new oxidative stress markers that can be used in this sense. On the subject of the proposed thesis; It is to determine the profile of dental and periodontal health in a specific group in terms of biochemical and microbiology using different body fluids together with clinical findings and has an interdisciplinary character. Aimed to be done in the planned thesis; It was aimed to evaluate the dental and periodontal health of patients with newly diagnosed JIA and healthy-periodontal problems with cytokines from saliva and oxidative stress markers non-invasively, and thus, to determine the markers' evaluability in terms of markers in determining the state of inflammation among individuals with and without the disease.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 114
Est. completion date September 1, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 16 Years
Eligibility Inclusion Criteria: - healty patients Exclusion Criteria: - used antibiotics within the last 3 months

Study Design


Intervention

Diagnostic Test:
Humans ELISA kits
ELISA (enzyme-linked immunosorbent assay) is a plate-based assay technique designed for detecting and quantifying soluble substances such as peptides, proteins, antibodies, and hormones. The saliva of the patients included in the study will be examined with ELISA kits after they are taken.

Locations

Country Name City State
Turkey Marmara University Faculty of Dentistry Istanbul Maltepe

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary biochemical evaluation of saliva in juvenile idiopathic arthritis Saliva samples were taken from the patients and the levels of interleukin-17, TNF alpha and Total antioxidant status in the saliva were measured with ELISA kits. baseline
Secondary Evaluation of oral hygiene in patients with juvenile idiopathic arthritis The number of caries in the patient was evaluated with the DMFT-dft index. baseline
Secondary Evaluation of periodontal health in patients with juvenile idiopathic arthritis Silness-Loe plaque index (PI) was used to assess periodontal health. baseline
Secondary Examination of periodontal health in patients with juvenile idiopathic arthritis Gingival index (GI) was also used to examination periodontal health. baseline
Secondary periodontal health in patients with juvenile idiopathic arthritis Bleeding on prob index were used for periodontal health examination. baseline
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