Biomarkers Associated With Temporomandibular Disorders in Patients With Rheumatoid Arthritis

NCT ID: NCT06488937

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2025-02-28

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.

Conditions

Temporomandibular Disorders; Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

RA patients

Patients that are diagnosed rheumatoid arthritis by their rheumatologist according to the 2010 European League Against Rheumatism/American College of Rheumatology classification criteria.

No interventions assigned to this group

Contorol group

The control group will be patients recruited from among regular patients visiting hospital for annual systematic examination in the same hospital.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rijeka Faculty of Dental Medicine

UNKNOWN

Sponsor Role: collaborator

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: lead

Responsible Party

Matea Dozet

DMD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Thalassoterapia Opatija, Specijalna bolnica za medicinsku rehabilitaciju bolesti srca, pluća i reumatizma

Opatija, Rijeka, Croatia

Countries

Croatia

References

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.

Reference Type: RESULT

PMID: 36484668 (View on PubMed)

Other Identifiers

IP2-FDMZ-2021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01-000-00-678-4./2019.

Identifier Type: -

Identifier Source: org_study_id