Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
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Purpose
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.
| Condition |
|---|
|
Rheumatoid Arthritis Osteoarthritis Periodontal Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis |
Blood specimens (serum, plasma and DNA)will be collected during a one time visit. Also bacterial samples will be collected from the gums of the subject's mouth.
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
In this study, we will examine whether PD and P. gingivalis impact 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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
UNebraskapatients Omaha VA Medical Center
Inclusion Criteria:
- Age 19 years or older
- Diagnosis of rheumatoid arthritis, osteoarthritis, or healthy control
- 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
Contacts and Locations| Contact: Debra A Bergman, MPH | 402-559-8846 | dabergma@unmc.edu |
| Contact: Bart C Hamilton, BS | 559-9036 | bchamilton@unmc.edu |
| United States, Nebraska | |
| Omaha Veteran Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Ted R Mikuls, MD, MSPH 402-559-7258 tmikuls@unmc.edu | |
| Principal Investigator: Ted R Mikuls, MD, MSPH | |
| Principal Investigator: | Ted R Mikuls, MD, MSPH | University of Nebraska |
More Information
No publications provided
| Responsible Party: | Ted Mikuls, MD, MSPH, University of Nebraska Medical Center |
| ClinicalTrials.gov Identifier: | NCT01156155 History of Changes |
| Other Study ID Numbers: | 342-10-FB |
| Study First Received: | June 30, 2010 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nebraska:
|
rheumatoid arthritis osteoarthritis periodontal diseaee |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Osteoarthritis Periodontal Diseases Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013