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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Periodontal Disease
• Intervention / Treatment: Radiation: Digital xray of jaw and teeth; Procedure: Blood draw; Other: questionnaires; Procedure: Periodontal Examination; Other: Bilateral digital xray of hands

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.

• Study Type: Observational
• Enrollment (Actual): 617

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Veterans Affairs Medical Center, Omaha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

UNebraskapatients Omaha VA Medical Center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Washington D.C. Veterans Affairs Medical Center; Dallas VA Medical Center; VA Salt Lake City Health Care System
• Investigators: Principal Investigator: Ted R Mikuls, MD, MSPH, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2010
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimated): July 2, 2010

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; periodontal disease
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Stomatognathic Diseases; Mouth Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Periodontal Diseases
• Other Study ID Numbers: 0342-10-FB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No