Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dallas VA Medical Center
Washington D.C. Veterans Affairs Medical Center
VA Salt Lake City Health Care System
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01156155
First received: June 30, 2010
Last updated: April 4, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

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.


Estimated Enrollment: 600
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Detailed Description:

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
Study Population

UNebraskapatients Omaha VA Medical Center

Criteria

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

Contacts
Contact: Debra A Bergman, MPH 402-559-8846 dabergma@unmc.edu
Contact: Bart C Hamilton, BS 559-9036 bchamilton@unmc.edu

Locations
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         
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, 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 April 23, 2014