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Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01156155
Enrollment
617
Registered
2010-07-02
Start date
2010-07-14
Completion date
2018-08-30
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Osteoarthritis, Periodontal Disease

Keywords

rheumatoid arthritis, osteoarthritis, periodontal disease

Brief 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.

Interventions

OTHERquestionnaires

completed questionnaires regarding patient's health and functional ability.

OTHERBilateral digital xray of hands

One time digital xray of hands

Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.

RADIATIONDigital xray of jaw and teeth

one time xray of jaw and teeth

PROCEDUREBlood draw

Three to four tablespoons of blood drawn.

Sponsors

Dallas VA Medical Center
CollaboratorFED
Washington D.C. Veterans Affairs Medical Center
CollaboratorFED
VA Salt Lake City Health Care System
CollaboratorFED
University of Nebraska
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Show the associations of periodontitis with RA are primarily due to infection with P. gingivaliswithin thirty days of enrollmentClinically 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026