Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborators:
Dallas VA Medical Center
Washington D.C. Veterans Affairs Medical Center
VA Salt Lake City Health Care System
Information provided by (Responsible Party):
Ted Mikuls, MD MSPH, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01156155
First received: June 30, 2010
Last updated: June 30, 2014
Last verified: May 2014
  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 Intervention
Rheumatoid Arthritis
Osteoarthritis
Periodontal Disease
Radiation: Digital xray of jaw and teeth
Procedure: Blood draw
Other: questionnaires
Procedure: Periodontal Examination
Other: Bilateral digital xray of hands

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis [ Time Frame: within thirty days of enrollment ] [ Designated as safety issue: No ]

    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.



Biospecimen Retention:   Samples With DNA

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.


Enrollment: 617
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Rheumatoid Arthritis
Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
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
Osteoarthritis
Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

UNebraskapatients Omaha VA Medical Center

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156155

Locations
United States, Nebraska
Omaha Veteran Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Dallas VA Medical Center
Washington D.C. Veterans Affairs Medical Center
VA Salt Lake City Health Care System
Investigators
Principal Investigator: Ted R Mikuls, MD, MSPH University of Nebraska
  More Information

No publications provided

Responsible Party: Ted Mikuls, MD MSPH, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01156155     History of Changes
Other Study ID Numbers: 342-10-FB
Study First Received: June 30, 2010
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
rheumatoid arthritis
osteoarthritis
periodontal disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Periodontal Diseases
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014