Rheumatoid ArthritisNCT01156155
Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by University of Nebraska at 1 site in United States.
Trial summary
Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the development RA. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Periodontal Disease
- What is being tested?
- Digital xray of jaw and teeth, Blood draw and questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 617 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2010to 30 Aug 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: UNebraskapatients Omaha VA Medical Center
Who may be able to join
- Age 19 years or older
- Diagnosis of rheumatoid arthritis, or osteoarthritis
- Have 9 or more evaluable posterior teeth (out of a total of 28 teeth, excluding third molars)
- Willing and able to provide informed consent
Who cannot join
- Received tetracyclines within the last 6 months.
- Need for antibiotic premedication for dental probing.
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center, Omaha
Omaha, Nebraska, 68105
About this study
Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the development RA. The objective of this study is to examine the relationship of PD and P. gingivalis infection with the risk and severity of RA.
Read the detailed description
In this study, we will examine whether periodontitis (PD) and P. gingivalis impact rheumatoid arthritis (RA) risk by enrolling 300 patients with RA and 300 comparator patients with osteoarthritis and comparing results from comprehensive dental examinations and antibody responses to P. gingivalis. We will examine whether these associations are modified by the presence of certain genetic risk factors previously implicated in RA and whether evidence of infection with P. gingivalis precedes RA onset by examining banked sera from the Department of Defense Serum Repository (DoDSR) and the Studies of the Etiology of RA (SERA). We also plan to explore whether there are novel proteins expressed by P. gingivalis that drive autoimmunity in RA and whether immune responses to these bacterial proteins predict the future development of RA.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Periodontal Disease
- Being tested
- Digital xray of jaw and teeth, Blood draw, questionnaires, Periodontal Examination, Bilateral digital xray of hands
- Keywords
- rheumatoid arthritis, osteoarthritis, periodontal disease
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital xray of jaw and teethRadiation
one time xray of jaw and teeth
Blood drawProcedure or surgery
Three to four tablespoons of blood drawn.
questionnairesOther
completed questionnaires regarding patient's health and functional ability.
Periodontal ExaminationProcedure or surgery
Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.
Bilateral digital xray of handsOther
One time digital xray of hands
| Study group | Role | What they receive |
|---|---|---|
| Participants with Rheumatoid Arthritis | Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands Receives: Radiation: Digital xray of jaw and teeth; Procedure: Blood draw; Other: questionnaires; Procedure: Periodontal Examination; Other: Bilateral digital xray of hands | |
| Osteoarthritis | Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Receives: Radiation: Digital xray of jaw and teeth; Procedure: Blood draw; Other: questionnaires; Procedure: Periodontal Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis
Clinically defined PD will be more common in RA patients than in controls. 1.B.: Clinically defined PD will be associated with greater RA disease severity including autoantibody status and the presence and extent of radiographic disease progression.
1.C.: The associations of clinically defined PD with RA risk and severity will be explained by the presence of antibody to P. gingivalis.
Measured: within thirty days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study start14 Jul 2010
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
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.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Dallas VA Medical Center, Washington D.C. Veterans Affairs Medical Center, VA Salt Lake City Health Care System
- Responsible party
- Sponsor
- Investigators
- Ted R Mikuls, MD, MSPH, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156155
- Sponsor's protocol ID
- 0342-10-FB
- Status last verified
- Oct 2023
- First submitted
- 30 Jun 2010
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01156155
- Acronym / sponsor ID
- 0342-10-FB
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Periodontal Disease
- Keywords
- rheumatoid arthritis, osteoarthritis, periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Dallas VA Medical Center, Washington D.C. Veterans Affairs Medical Center, VA Salt Lake City Health Care System
- Study start
- 14 Jul 2010 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 2 Jul 2010 (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.
Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the development RA. The objective of this study is to examine the relationship of PD and P. gingivalis infection with the risk and severity of RA.
Detailed description
In this study, we will examine whether periodontitis (PD) and P. gingivalis impact rheumatoid arthritis (RA) risk by enrolling 300 patients with RA and 300 comparator patients with osteoarthritis and comparing results from comprehensive dental examinations and antibody responses to P. gingivalis. We will examine whether these associations are modified by the presence of certain genetic risk factors previously implicated in RA and whether evidence of infection with P. gingivalis precedes RA onset by examining banked sera from the Department of Defense Serum Repository (DoDSR) and the Studies of the Etiology of RA (SERA). We also plan to explore whether there are novel proteins expressed by P. gingivalis that drive autoimmunity in RA and whether immune responses to these bacterial proteins predict the future development of RA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Rheumatoid Arthritis | – | Radiation: Digital xray of jaw and teeth, Procedure: Blood draw, Other: questionnaires, Procedure: Periodontal Examination, Other: Bilateral digital xray of handsRheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands |
| Osteoarthritis | – | Radiation: Digital xray of jaw and teeth, Procedure: Blood draw, Other: questionnaires, Procedure: Periodontal ExaminationOsteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- UNebraskapatients Omaha VA Medical Center
Key inclusion criteria (4 listed)
- Age 19 years or older
- Diagnosis of rheumatoid arthritis, or osteoarthritis
- Have 9 or more evaluable posterior teeth (out of a total of 28 teeth, excluding third molars)
- Willing and able to provide informed consent
Key exclusion criteria (3 listed)
- Received tetracyclines within the last 6 months.
- Need for antibiotic premedication for dental probing.
- Pregnant or breast feeding
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 |
|---|---|---|
| Digital xray of jaw and teethone time xray of jaw and teeth | Radiation | Osteoarthritis, Participants with Rheumatoid Arthritis |
| Blood drawThree to four tablespoons of blood drawn. | Procedure or surgery | Osteoarthritis, Participants with Rheumatoid Arthritis |
| questionnairescompleted questionnaires regarding patient's health and functional ability. | Other | Osteoarthritis, Participants with Rheumatoid Arthritis |
| Periodontal ExaminationPeriodontal examination including measurement of gum pockets with a probe. Bacterial samples taken. | Procedure or surgery | Osteoarthritis, Participants with Rheumatoid Arthritis |
| Bilateral digital xray of handsOne time digital xray of hands | Other | Participants with Rheumatoid Arthritis |
Primary outcome
Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis
Time frame: within thirty days of enrollment
Clinically defined PD will be more common in RA patients than in controls. 1.B.: Clinically defined PD will be associated with greater RA disease severity including autoantibody status and the presence and extent of radiographic disease progression. 1.C.: The associations of clinically defined PD with RA risk and severity will be explained by the presence of antibody to P. gingivalis.
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 2 Nov 2023.
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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.
Ted R Mikuls, MD, MSPH principal investigator
University of Nebraska
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 Rheumatoid Arthritis and Osteoarthritis, run by University of Nebraska at 1 site in United States.
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 3 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 2 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 United States. 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?
Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis (time frame: within thirty days of enrollment). 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 2 Nov 2023.