NCT06134726

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 3, 2023

Last Update Submit

November 17, 2023

Conditions

Temporomandibular Joint DisordersRheumatoid Arthritis

Keywords

Rheumatoid arthritisTemporomandibular jointsBruxism

Outcome Measures

Primary Outcomes (2)

  • Number of patients with prevalence of TMD

    patients were interviewed, filled out the questionnaire, and examined

    2 years

  • Number of patients with TMD-pain diagnoses

    patients were interviewed, filled out the questionnaire, and examined

    2 years

Study Arms (2)

RA group

Diagnostic Test: seropositivity of rheumatoid factor

Control group

Diagnostic Test: seropositivity of rheumatoid factor

Interventions

seropositivity of rheumatoid factorDIAGNOSTIC_TEST

All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies

Also known as: anticitrullinated protein antibodies
Control groupRA group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Damascus University, Syria

Damascus, 1, Syria

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersArthritis, RheumatoidBruxism

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor Diaa Haj Ali

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 18, 2023

Study Start

January 15, 2021

Primary Completion

January 1, 2023

Study Completion

January 15, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

SY(1)