Temporomandibular Joint in Patients With Rheumatoid Arthritis

• Sponsor: Syrian Private University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06134726
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Disorders; Rheumatoid Arthritis	Diagnostic Test: seropositivity of rheumatoid factor

Study Design

• Study Type: Observational
• Actual Enrollment: 142 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Temporomandibular Joint in Patients With Rheumatoid Arthritis
• Actual Study Start Date: Jan 15, 2021
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Number of patients with prevalence of TMD [2 years]

   patients were interviewed, filled out the questionnaire, and examined

2. Number of patients with TMD-pain diagnoses [2 years]

   patients were interviewed, filled out the questionnaire, and examined

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Damascus University, Syria	Damascus		Syrian Arab Republic	1

Sponsors and Collaborators

• Syrian Private University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diaa Haj Ali, medical doctor Diaa Haj Ali, Syrian Private University
• ClinicalTrials.gov Identifier: NCT06134726
• Other Study ID Numbers: BX63413,2021
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Diaa Haj Ali, medical doctor Diaa Haj Ali, Syrian Private University: Rheumatoid arthritis; Temporomandibular joints; Bruxism
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Rheumatoid Factor

Study Results

No Results Posted as of Nov 21, 2023