Temporomandibular Joint DisordersNCT06134726
Temporomandibular Joint in Patients With Rheumatoid Arthritis
An observational study of Temporomandibular Joint Disorders and Rheumatoid Arthritis, run by Syrian Private University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Rheumatoid Arthritis
- What is being tested?
- seropositivity of rheumatoid factor
- How many people
- 142 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jan 2021to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls
Who may be able to join
- age > 18 years old
- individuals who had a minimum of 12 natural teeth.
Who cannot join
- included: trauma or surgery on the jaw
- facial nerve paralysis
- tooth implant
- scleroderma
- cerebrovascular accident
- schizophrenia
- steroid injection within the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- seropositivity of rheumatoid factor
- Keywords
- Rheumatoid arthritis, Temporomandibular joints, Bruxism
- Medical subject headings
- Temporomandibular Joint Disorders, Arthritis, Rheumatoid, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seropositivity of rheumatoid factorDiagnostic test
Also called anticitrullinated protein antibodies
All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies
| Study group | Role | What they receive |
|---|---|---|
| RA group | Not described Receives: Diagnostic Test: seropositivity of rheumatoid factor | |
| Control group | Not described Receives: Diagnostic Test: seropositivity of rheumatoid factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with prevalence of TMD
patients were interviewed, filled out the questionnaire, and examined
Measured: 2 years
Number of patients with TMD-pain diagnoses
patients were interviewed, filled out the questionnaire, and examined
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Jan 2021
- Primary completion1 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syrian Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaa Haj Ali, Syrian Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134726
- Sponsor's protocol ID
- BX63413,2021
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Joint in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06134726
- Acronym / sponsor ID
- BX63413,2021
- Keywords
- Rheumatoid arthritis, Temporomandibular joints, Bruxism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Syrian Private UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA group | – | Diagnostic Test: seropositivity of rheumatoid factor |
| Control group | – | Diagnostic Test: seropositivity of rheumatoid factor |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls
Key inclusion criteria (2 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seropositivity of rheumatoid factorAlso: anticitrullinated protein antibodiesAll participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies | Diagnostic test | Control group, RA group |
Primary outcome
Number of patients with prevalence of TMD
Time frame: 2 years
patients were interviewed, filled out the questionnaire, and examined
Number of patients with TMD-pain diagnoses
Time frame: 2 years
patients were interviewed, filled out the questionnaire, and examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders and Rheumatoid Arthritis, run by Syrian Private University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with prevalence of TMD (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.