Expired Study
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Omaha, Nebraska 68105


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

342-10-FB


NCT ID:

NCT01156155


Secondary ID:


Study Acronym:


Brief Title:

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis


Official Title:

Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Nebraska


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

617


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ted R Mikuls, MD, MSPH
Principal Investigator
University of Nebraska

Study Dates

Start Date:July 2010
Completion Date:July 2012
Completion Type:Actual
Primary Completion Date:July 2012
Primary Completion Type:Actual
Verification Date:May 2014
Last Changed Date:June 30, 2014
First Received Date:June 30, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Show the associations of periodontitis with RA are primarily due to infection with P. gingivalis
Time Frame:within thirty days of enrollment
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Other
Name:Bilateral digital xray of hands
Description:One time digital xray of hands
Arm Name:Participants with Rheumatoid Arthritis
Intervention Type:Procedure
Name:Periodontal Examination
Description:Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.
Arm Name:Participants with Rheumatoid Arthritis
Intervention Type:Other
Name:questionnaires
Description:completed questionnaires regarding patient's health and functional ability.
Arm Name:Participants with Rheumatoid Arthritis
Intervention Type:Procedure
Name:Blood draw
Description:Three to four tablespoons of blood drawn.
Arm Name:Participants with Rheumatoid Arthritis
Intervention Type:Radiation
Name:Digital xray of jaw and teeth
Description:one time xray of jaw and teeth
Arm Name:Participants with Rheumatoid Arthritis

Study Arms

Study Arm Type:Other
Arm Name:Osteoarthritis
Description:Osteoarthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination
Study Arm Type:Other
Arm Name:Participants with Rheumatoid Arthritis
Description:Rheumatoid arthritis patients Digital xray of jaw and teeth Blood draw questionnaires Periodontal Examination Bilateral digital xray of hands

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Nebraska
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Dallas VA Medical Center

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood specimens (serum, plasma and DNA)will be collected during a one time visit. Also bacterial samples will be collected from the gums of the subject's mouth.
Study Population: UNebraskapatients Omaha VA Medical Center
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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