Clinical Trials Directory

Trials / Completed

CompletedNCT01156155

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Status
Completed
Phase
Study type
Observational
Enrollment
617 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONDigital xray of jaw and teethone time xray of jaw and teeth
PROCEDUREBlood drawThree to four tablespoons of blood drawn.
OTHERquestionnairescompleted questionnaires regarding patient's health and functional ability.
PROCEDUREPeriodontal ExaminationPeriodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.
OTHERBilateral digital xray of handsOne time digital xray of hands

Timeline

Start date
2010-07-14
Primary completion
2018-08-30
Completion
2018-08-30
First posted
2010-07-02
Last updated
2023-11-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01156155. Inclusion in this directory is not an endorsement.