Temporomandibular Joint in Patients With Rheumatoid Arthritis

November 17, 2023 updated by: Diaa Haj Ali, Syrian Private University
the investigators study aimed to evaluate temporomandibular joint involvement in rheumatoid arthritis patients and healthy individuals 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls. All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies. TMD diagnosis was determined according to the standardized and validated diagnostic criteria for TMD (DC/TMD): myalgia, arthralgia, articular disc, displacement, degenerative joint disease, and headache attributed to TMD. Bruxism, a probable sleep and/or awake bruxism diagnosis was determined based on self-report and several clinical findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, 1
        • Faculty of Medicine, Damascus University, Syria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls

Description

  • Inclusion criteria included:

    • age > 18 years old
    • individuals who had a minimum of 12 natural teeth.

  • Exclusion criteria

    • included: trauma or surgery on the jaw
    • facial nerve paralysis
    • tooth implant
    • scleroderma
    • cerebrovascular accident
    • schizophrenia
    • steroid injection within the last six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Diagnostic test: seropositivity of rheumatoid factor
All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies
Other Names:
  • anticitrullinated protein antibodies
RA group
Diagnostic test: seropositivity of rheumatoid factor
All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies
Other Names:
  • anticitrullinated protein antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with prevalence of TMD
Time Frame: 2 years
patients were interviewed, filled out the questionnaire, and examined
2 years
Number of patients with TMD-pain diagnoses
Time Frame: 2 years
patients were interviewed, filled out the questionnaire, and examined
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syrian Private University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX63413,2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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