Clinical trial NCT06488937: Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis
Official title: Determinants of Orofacial Pain and Temporomandibular Disorders in People With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Temporomandibular Disorders
Rheumatoid Arthritis
Keywords: RA
rheumatoid arthritis
TMDs
temporomandibular disorders
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
Collaborators: name: University of Rijeka Faculty of Dental Medicine
First posted: 2024-07-05
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RA were recruited during their routine monitoring by rheumatologists.

The control group were recruited from among regular patients visiting hospital for annual systematic examination.

Brief 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.

Detailed description: Rheumatoid arthritis (RA) is chronic inflammatory autoimmune disease characterized by symmetrical peripheral polyarthritis with consequent joint destruction. Predominantly affecting wrist and foot joints, RA can also affect temporomandibular joint (TMJ) causing temporomandibular disorders (TMDs). 4-80% of RA patients suffer from TMDs.

It remains unclear why some RA patients do not have TMDs and don't suffer from orofacial pain, depression and somatization. The present study was therefore designed to explore the level of cytokines and biochemical parameters from saliva and serum in RA patients and control participants to examine their correlation with TMDs. Study results could provide valuable insights for the understanding of the orofacial pain and depression onset in RA patients Participants would be examined by a non-blinded examiner with knowledge to which group the patient was in. After intraoral examination Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) will be used as an international diagnostic protocol for TMDs. Assessment included clinical examination of TMJs and masticatory muscles with measurement of mandibular dynamics. The participants will be requested to spit 2 mL of unstimulated saliva into a sterile tube with their head slightly bended forward. Saliva samples were stored at -20℃ until analysis. Blood samples will be collected in Vacutaners. Serum calcium (Ca), magnesium (Mg), phosphate (P), uric acid, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT) were measured up to 6 hours after collection. Serum aliquots were stored at -20℃ until cytokine analysis. An Invitrogen assays were used to analyze salivary and serum concentration of IL-4,IL-18 and IFN-γ.

Eligibility criteria: 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

Primary outcomes:
measure: levels of cytokines IL-4, IL-18, IFN-γ in serum
timeFrame: baseline
measure: levels of cytokines IL-4, IL-18, IFN-γ in saliva
timeFrame: baseline
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Opatija
country: Croatia
facility: Thalassoterapia Opatija, Specijalna bolnica za medicinsku rehabilitaciju bolesti srca, pluća i reumatizma
state: Rijeka
Study officials:
References:
citation: Mesic VF, Laskarin AM, Kehler T, Spalj S, Dozet M, Pavicic DK. Characteristics of Temporomandibular Disorders and Orofacial Pain in Individuals with Rheumatoid Arthritis. Int J Prosthodont. 2023 Nov 1;36(5):630-636. doi: 10.11607/ijp.8145.