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OpenTrials
Completed

NCT Number: NCT01156155

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Mouth Diseases Musculoskeletal Diseases Osteoarthritis Periodontal Disease Periodontal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Veterans Affairs Medical Center, Omaha

Omaha, Nebraska, 68105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital xray of jaw and teeth

Radiation

one time xray of jaw and teeth

Blood draw

Procedure

Three to four tablespoons of blood drawn.

questionnaires

Other

completed questionnaires regarding patient's health and functional ability.

Periodontal examination

Procedure

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

Bilateral digital xray of hands

Other

One time digital xray of hands

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Dallas VA Medical Center
  • VA Salt Lake City Health Care System
  • Washington D.C. Veterans Affairs Medical Center

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2010
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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