Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
October 31, 2023 updated by: University of Nebraska
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
617
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68105
- Veterans Affairs Medical Center, Omaha
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
UNebraskapatients Omaha VA Medical Center
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Received tetracyclines within the last 6 months.
- Need for antibiotic premedication for dental probing.
- Pregnant or breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants with Rheumatoid Arthritis
Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
|
one time xray of jaw and teeth
Three to four tablespoons of blood drawn.
completed questionnaires regarding patient's health and functional ability.
Periodontal examination including measurement of gum pockets with a probe.
Bacterial samples taken.
One time digital xray of hands
|
|
Osteoarthritis
Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
|
one time xray of jaw and teeth
Three to four tablespoons of blood drawn.
completed questionnaires regarding patient's health and functional ability.
Periodontal examination including measurement of gum pockets with a probe.
Bacterial samples taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
within thirty days of enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ted R Mikuls, MD, MSPH, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2010
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
June 30, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimated)
July 2, 2010
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0342-10-FB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.