Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Completed

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

• Registration Number: NCT01156155
• Lead Sponsor: University of Nebraska

Brief 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.

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 Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-02
• Study Start: 2010-07-14
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis	questionnaires	Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
Participants with Rheumatoid Arthritis	Blood draw	Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
Participants with Rheumatoid Arthritis	Periodontal Examination	Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
Osteoarthritis	Blood draw	Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
Osteoarthritis	Periodontal Examination	Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
Participants with Rheumatoid Arthritis	Digital xray of jaw and teeth	Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
Participants with Rheumatoid Arthritis	questionnaires	Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
Participants with Rheumatoid Arthritis	Bilateral digital xray of hands	Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands
Osteoarthritis	Digital xray of jaw and teeth	Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination

Primary Outcome Measures

Name	Time	Method
Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis	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.

Trial Locations

Locations (1)

Veterans Affairs Medical Center, Omaha; 🇺🇸 Omaha, Nebraska, United States