Trials / Completed
CompletedNCT01156155
Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 617 (actual)
- Sponsor
- University of Nebraska · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Digital xray of jaw and teeth | one time xray of jaw and teeth |
| PROCEDURE | Blood draw | Three to four tablespoons of blood drawn. |
| OTHER | questionnaires | completed questionnaires regarding patient's health and functional ability. |
| PROCEDURE | Periodontal Examination | Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken. |
| OTHER | Bilateral digital xray of hands | One time digital xray of hands |
Timeline
- Start date
- 2010-07-14
- Primary completion
- 2018-08-30
- Completion
- 2018-08-30
- First posted
- 2010-07-02
- Last updated
- 2023-11-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01156155. Inclusion in this directory is not an endorsement.