Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

617 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-14

Study Completion Date

2018-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

NCT02905175

Rheumatoid Arthritis

COMPLETED

Oral Metagenomic Biomarkers in Rheumatoid Arthritis

NCT02544334

Rheumatoid Arthritis

COMPLETED

Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

NCT02794012

Rheumatoid Arthritis Periodontal Disease

COMPLETED

Relationship of Periodontitis and Cardiovascular Risk in Patients With Rheumatoid Arthritis

NCT03506165

Rheumatoid Arthritis Periodontitis

UNKNOWN NA

Dental Prophylaxis and Rheumatoid Arthritis

NCT03087240

Rheumatoid Arthritis Periodontitis Gingivitis +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis Osteoarthritis Periodontal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with Rheumatoid Arthritis

Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands

Digital xray of jaw and teeth

Intervention Type RADIATION

one time xray of jaw and teeth

Blood draw

Intervention Type PROCEDURE

Three to four tablespoons of blood drawn.

questionnaires

Intervention Type OTHER

completed questionnaires regarding patient's health and functional ability.

Periodontal Examination

Intervention Type PROCEDURE

Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.

Bilateral digital xray of hands

Intervention Type OTHER

One time digital xray of hands

Osteoarthritis

Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination

Digital xray of jaw and teeth

Intervention Type RADIATION

one time xray of jaw and teeth

Blood draw

Intervention Type PROCEDURE

Three to four tablespoons of blood drawn.

questionnaires

Intervention Type OTHER

completed questionnaires regarding patient's health and functional ability.

Periodontal Examination

Intervention Type PROCEDURE

Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital xray of jaw and teeth

one time xray of jaw and teeth

Intervention Type RADIATION

Blood draw

Three to four tablespoons of blood drawn.

Intervention Type PROCEDURE

questionnaires

completed questionnaires regarding patient's health and functional ability.

Intervention Type OTHER

Periodontal Examination

Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.

Intervention Type PROCEDURE

Bilateral digital xray of hands

One time digital xray of hands

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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