Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794012
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis. Subjects will undergo periodontal and joint examinations, as well as collection of body fluids to measure Rheumatoid Arthritis-related antibodies.

Condition or disease
Rheumatoid Arthritis Periodontal Disease

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
At-Risk Rheumatoid Arthritis subjects
Early Rheumatoid Arthritis subjects
Healthy Controls
Non-Rheumatoid Arthritis Autoimmune Controls


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR) [ Time Frame: 1 day ]
  2. Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays [ Time Frame: 1 day ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls >40 years old.
Criteria

Inclusion Criteria:

  • Rheumatoid Arthritis-antibody positivity (anti-CCP) in the absence of arthritis or
  • Early RA <36 months since diagnosis

Exclusion Criteria:

  • Pregnancy
  • Antibiotic use prior to dental procedures or cleanings
  • Wear dentures
  • <18 years old
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794012


Locations
Layout table for location information
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Rheumatology Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Lindsay B Kelmenson, MD University of Colorado, Denver
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02794012    
Other Study ID Numbers: 15-2288
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Periodontal Diseases
Inflammation
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mouth Diseases
Stomatognathic Diseases