Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156155
• Other study ID #: 0342-10-FB
• Status: Completed
• Start date: July 14, 2010
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Periodontal Disease
• Periodontal Diseases
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center, Omaha	Omaha	Nebraska

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis	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.	within thirty days of enrollment