NCT05217277

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 21, 2022

Last Update Submit

February 18, 2022

Conditions

Juvenile Idiopathic ArthritisGingivitisDecay, Dental

Keywords

pediatric dentistryperiodontal statusjuvenile idiopathic arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evaluation of oral hygiene in patients with juvenile idiopathic arthritis

    baseline

  • Evaluation of periodontal health in patients with juvenile idiopathic arthritis

    baseline

  • Examination of periodontal health in patients with juvenile idiopathic arthritis

    baseline

  • periodontal health in patients with juvenile idiopathic arthritis

    baseline

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: Humans ELISA kits

Interventions

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.

healthy patient group with gingivitishealthy patient group without gingivitispatient with juvenile idiopathic arthritis and gingivitispatient with juvenile idiopathic arthritis and without gingivitis

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients who have no disease other than juvenile idiopathic arthritis, newly diagnosed and not yet using medication.

You may qualify if:

  • healty patients

You may not qualify if:

  • used antibiotics within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Maltepe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, JuvenileGingivitisDental Caries

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DemineralizationTooth Diseases

Study Officials

  • Betul Sozeri

    researcher

    STUDY CHAIR

  • Ferhat Demir

    researcher

    STUDY CHAIR

  • Selin Yıldırım

    researcher

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 1, 2022

Study Start

May 6, 2020

Primary Completion

May 15, 2022

Study Completion

September 1, 2022

Last Updated

February 21, 2022

Record last verified: 2022-01

Locations

TU(1)