NCT06488937

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 5, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

June 28, 2024

Last Update Submit

June 28, 2024

Conditions

Temporomandibular DisordersRheumatoid Arthritis

Keywords

RArheumatoid arthritisTMDstemporomandibular disorders

Outcome Measures

Primary Outcomes (3)

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

    Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific

    baseline

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

    Invitrogen assays will be used for multicomplex quantitative analysis of inflammatory mediators. The entire protocol will be carried out according to the instructions of the manufacturer of Thermofischer Scientific

    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

    measured up to 6 hours after collection on Roche Cobas c501 biochemistry analyzer

    baseline

Study Arms (2)

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.

Contorol group

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to sign informed consent form
  • Diagnosed chronic systemic disease
  • Any infection including TB, HIV, Hepatitis B or C
  • Malignancy
  • Pregnancy
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Opatija, Rijeka, 51101, Croatia

Location

Related Publications (1)

  • 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.

    PMID: 36484668RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva will be retained.

MeSH Terms

Conditions

Temporomandibular Joint DisordersArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMD

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 5, 2024

Study Start

November 1, 2019

Primary Completion

May 30, 2022

Study Completion

February 1, 2025

Last Updated

July 5, 2024

Record last verified: 2024-06

Locations

CR(1)