NCT01156155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
617

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

July 14, 2010

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

8.1 years

First QC Date

June 30, 2010

Last Update Submit

October 31, 2023

Conditions

Rheumatoid ArthritisOsteoarthritisPeriodontal Disease

Keywords

rheumatoid arthritisosteoarthritisperiodontal disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 teethProcedure: Blood drawOther: questionnairesProcedure: Periodontal ExaminationOther: Bilateral digital xray of hands

Osteoarthritis

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

Radiation: Digital xray of jaw and teethProcedure: Blood drawOther: questionnairesProcedure: Periodontal Examination

Interventions

Digital xray of jaw and teethRADIATION

one time xray of jaw and teeth

OsteoarthritisParticipants with Rheumatoid Arthritis
Blood drawPROCEDURE

Three to four tablespoons of blood drawn.

OsteoarthritisParticipants with Rheumatoid Arthritis
questionnairesOTHER

completed questionnaires regarding patient's health and functional ability.

OsteoarthritisParticipants with Rheumatoid Arthritis
Periodontal ExaminationPROCEDURE

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

OsteoarthritisParticipants with Rheumatoid Arthritis
Bilateral digital xray of handsOTHER

One time digital xray of hands

Participants with Rheumatoid Arthritis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UNebraskapatients Omaha VA Medical Center

You may qualify if:

  • 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

You may not qualify if:

  • Received tetracyclines within the last 6 months.
  • Need for antibiotic premedication for dental probing.
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center, Omaha

Omaha, Nebraska, 68105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritisPeriodontal Diseases

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ted R Mikuls, MD, MSPH

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

July 14, 2010

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

US(1)