Juvenile Idiopathic ArthritisNCT05217277
Clinical and Biochemical Evaluation of Dental and Periodontal Conditions in Children With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis and Gingivitis, run by Marmara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Gingivitis, Decay, Dental
- What is being tested?
- Humans ELISA kits
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients who have no disease other than juvenile idiopathic arthritis, newly diagnosed and not yet using medication.
Who may be able to join
- healty patients
Who cannot join
- used antibiotics within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Maltepe
About this study
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis, Gingivitis, Decay, Dental
- Being tested
- Humans ELISA kits
- Keywords
- pediatric dentistry, periodontal status, juvenile idiopathic arthritis
- Medical subject headings
- Arthritis, Juvenile, Gingivitis, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humans ELISA kitsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Humans ELISA kits | |
| 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. Receives: Diagnostic Test: Humans ELISA kits | |
| 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. Receives: Diagnostic Test: Humans ELISA kits | |
| 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. Receives: Diagnostic Test: Humans ELISA kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
Evaluation of oral hygiene in patients with juvenile idiopathic arthritis
The number of caries in the patient was evaluated with the DMFT-dft index.
Measured: baseline
Evaluation of periodontal health in patients with juvenile idiopathic arthritis
Silness-Loe plaque index (PI) was used to assess periodontal health.
Measured: baseline
Examination of periodontal health in patients with juvenile idiopathic arthritis
Gingival index (GI) was also used to examination periodontal health.
Measured: baseline
periodontal health in patients with juvenile idiopathic arthritis
Bleeding on prob index were used for periodontal health examination.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 May 2020
- Primary completion15 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Sozeri, Study chair, researcherFerhat Demir, Study chair, researcherSelin Yıldırım, Study chair, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217277
- Sponsor's protocol ID
- 2019-146
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Dental and Periodontal Conditions in Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05217277
- Acronym / sponsor ID
- 2019-146
- Conditions
- Juvenile Idiopathic Arthritis, Gingivitis, Decay, Dental
- Keywords
- pediatric dentistry, periodontal status, juvenile idiopathic arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patient with juvenile idiopathic arthritis and gingivitis | – | Diagnostic Test: Humans ELISA kitsIt 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. |
| healthy patient group with gingivitis | – | Diagnostic Test: Humans ELISA kitsIt is a group of healthy patients with gingivitis between the ages of 5-16 who have not taken antibiotics in the last 3 months. |
| healthy patient group without gingivitis | – | Diagnostic Test: Humans ELISA kitsIt is a group of healthy patients without gingivitis between the ages of 5-16 who have not taken antibiotics in the last 3 months. |
| patient with juvenile idiopathic arthritis and without gingivitis | – | Diagnostic Test: Humans ELISA kitsIt 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients who have no disease other than juvenile idiopathic arthritis, newly diagnosed and not yet using medication.
Key inclusion criteria (1 listed)
- healty patients
Key exclusion criteria (1 listed)
- used antibiotics within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humans ELISA kitsELISA (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. | Diagnostic test | healthy patient group with gingivitis, healthy patient group without gingivitis, patient with juvenile idiopathic arthritis and gingivitis, patient with juvenile idiopathic arthritis and without gingivitis |
Primary outcome
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.
4 secondary outcomes
Evaluation of oral hygiene in patients with juvenile idiopathic arthritis
Time frame: baseline
Evaluation of periodontal health in patients with juvenile idiopathic arthritis
Time frame: baseline
Examination of periodontal health in patients with juvenile idiopathic arthritis
Time frame: baseline
periodontal health in patients with juvenile idiopathic arthritis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betul Sozeri study chair
researcher
Ferhat Demir study chair
researcher
Selin Yıldırım study chair
researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Gingivitis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical evaluation of saliva in juvenile idiopathic arthritis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.