Rheumatoid ArthritisNCT01616641
Orofacial Evaluation in Women With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Federal University of São Paulo.
Trial summary
Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in the physical examination of patients with RA, the joints in the area of the jaw and neck may also be affected in this disease and have their involvement usually underdiagnosed. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2012
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 150 individuals, half of them, 75 were rheumatoid arthritis and the others 75 consisted the group control
Who may be able to join
- RA group:
- rheumatoid arthritis (American College of Rheumatology)
- Control group:
- healthy
Who cannot join
- edentate be total, have been subjected to surgical procedure in the last six months in the region of the hands or oral maxillo facial
About this study
Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in the physical examination of patients with RA, the joints in the area of the jaw and neck may also be affected in this disease and have their involvement usually underdiagnosed. There are few studies evaluating the incidence of orofacial alteration in the examination as well as the correlation between bite force (BF) and clinical and functional parameters in these patients. The aim of our study was to chacacterize the orofacial alterations in RA patients, correlate the results of the orofacial evaluation with clinical and disease activity parameters, and correlate the bite force with the hand strenght.
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, bite force, grip strenght, oral health, quality of life
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis group | 75 patients with rheumatoid arthritis | |
| control group | 75 healthy women |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, carmen paz santibanez hoyuela, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616641
- Sponsor's protocol ID
- Orofacial
- Status last verified
- Jun 2012
- First submitted
- 8 Jun 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orofacial Evaluation in Women With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01616641
- Acronym / sponsor ID
- Orofacial
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, bite force, grip strenght, oral health, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jun 2011
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- 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.
Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in the physical examination of patients with RA, the joints in the area of the jaw and neck may also be affected in this disease and have their involvement usually underdiagnosed. There are few studies evaluating the incidence of orofacial alteration in the examination as well as the correlation between bite force (BF) and clinical and functional parameters in these patients. The aim of our study was to chacacterize the orofacial alterations in RA patients, correlate the results of the orofacial evaluation with clinical and disease activity parameters, and correlate the bite force with the hand strenght.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis group | – | –75 patients with rheumatoid arthritis |
| control group | – | –75 healthy women |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 150 individuals, half of them, 75 were rheumatoid arthritis and the others 75 consisted the group control
Key inclusion criteria (4 listed)
- rheumatoid arthritis (American College of Rheumatology)
- healthy
Key exclusion criteria (1 listed)
- edentate be total, have been subjected to surgical procedure in the last six months in the region of the hands or oral maxillo facial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Federal University of São Paulo.
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 4 inclusion and 1 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 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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 12 Jun 2012.