- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05217277
Clinical and Biochemical Evaluation of Dental and Periodontal Conditions in Children With Juvenile Idiopathic Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey
- Marmara University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- healty patients
Exclusion Criteria:
- used antibiotics within the last 3 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patient with juvenile idiopathic arthritis and gingivitis
It is a group of patients between the ages of 5 and 16 who have recently been diagnosed with juvenile idiopathic arthritis and gingivitis, have not used medication yet.
|
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. |
|
healthy patient group with gingivitis
It is a group of healthy patients with gingivitis between the ages of 5-16 who have not taken antibiotics in the last 3 months.
|
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. |
|
healthy patient group without gingivitis
It is a group of healthy patients without gingivitis between the ages of 5-16 who have not taken antibiotics in the last 3 months.
|
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. |
|
patient with juvenile idiopathic arthritis and without gingivitis
It is a group of patients between the ages of 5 and 16 who have recently been diagnosed with juvenile idiopathic arthritis and without gingivitis, have not used medication yet.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biochemical evaluation of saliva in juvenile idiopathic arthritis
Time Frame: baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of oral hygiene in patients with juvenile idiopathic arthritis
Time Frame: baseline
|
The number of caries in the patient was evaluated with the DMFT-dft index.
|
baseline
|
|
Evaluation of periodontal health in patients with juvenile idiopathic arthritis
Time Frame: baseline
|
Silness-Loe plaque index (PI) was used to assess periodontal health.
|
baseline
|
|
Examination of periodontal health in patients with juvenile idiopathic arthritis
Time Frame: baseline
|
Gingival index (GI) was also used to examination periodontal health.
|
baseline
|
|
periodontal health in patients with juvenile idiopathic arthritis
Time Frame: baseline
|
Bleeding on prob index were used for periodontal health examination.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Betul Sozeri, Researcher
- Study Chair: Ferhat Demir, Researcher
- Study Chair: Selin Yıldırım, Researcher
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Gingival Diseases
- Tooth Demineralization
- Tooth Diseases
- Arthritis
- Gingivitis
- Dental Caries
- Arthritis, Juvenile
Other Study ID Numbers
- 2019-146
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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