Active — Not RecruitingNot Applicable

Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis

Croatia92 participantsStarted 2019-11-01

Plain-language summary

The goal of this observational study is to determinate temeporomandibular disorders (TMDs) and levels of biomarkers in 30 rheumatoid arthritis patients and 30 healthy controls. Aims are: * to determine TMDs symptoms in both groups using a validated Reasearch Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) protocol * to determine levels of interleukin-4 (IL-4), interleukin-18 (IL-18) and interferon-gamma (IFN-γ) in saliva and serum in RA patients and control group * to determine levels of biomarkers (Ca, Mg, P, AST,ALT,ALP,GGT,urate) in serum of RA patients and control group * investigate the correlation between cytokines level in saliva and serum * to determine the effect of TMDs on cytokine and biomarker levels Participants will be clinicaly examined by DMD in accordance with the RDC/TMD guidelines to receive both Axis I and Axis II diagnoses. After examination participants would be asked for saliva and blood sample.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study * Patients diagnosed with RA according to 2010 ACR-EULAR RA criteria. Exclusion Criteria: * Refusal to sign informed consent form * Diagnosed chronic systemic disease * Any infection including TB, HIV, Hepatitis B or C * Malignancy * Pregnancy * Smokers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

levels of cytokines IL-4, IL-18, IFN-γ in serum

Timeframe: baseline

levels of cytokines IL-4, IL-18, IFN-γ in saliva

Timeframe: baseline

levels of calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma- glutamyltransferase (GGT) in serum

Timeframe: baseline

Trial details

NCT IDNCT06488937

SponsorJosip Juraj Strossmayer University of Osijek

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-30

View on ClinicalTrials.gov More Temporomandibular Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

levels of cytokines IL-4, IL-18, IFN-γ in serum

Timeframe: baseline

levels of cytokines IL-4, IL-18, IFN-γ in saliva

Timeframe: baseline