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Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

This study is currently recruiting participants.
Verified August 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02794012
First Posted: June 8, 2016
Last Update Posted: August 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Rheumatology Research Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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
Rheumatoid Arthritis Periodontal Disease

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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

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

Estimated Enrollment: 180
Actual Study Start Date: July 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
At-Risk Rheumatoid Arthritis subjects
Early Rheumatoid Arthritis subjects
Healthy Controls
Non-Rheumatoid Arthritis Autoimmune Controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
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


Contacts
Contact: Lindsay B Kelmenson, MD 303-724-0082 lindsay.kelmenson@ucdenver.edu
Contact: Laura Lenis 303-724-0071 laura.lenischarry@UCDENVER.EDU

Locations
United States, Colorado
Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Lindsay B Kelmenson, MD    303-724-0082    lindsay.kelmenson@ucdenver.edu   
Contact: Laura Lenis    303-724-0071    laura.lenischarry@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Rheumatology Research Foundation
Investigators
Principal Investigator: Lindsay B Kelmenson, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02794012     History of Changes
Other Study ID Numbers: 15-2288
First Submitted: May 26, 2016
First Posted: June 8, 2016
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Periodontal Diseases
Gingival Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases