Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Mouth Diseases Musculoskeletal Diseases Periodontal Disease Periodontal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines

Time frame: 1 day

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Rheumatology Research Foundation

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 8, 2016
Registry last updated: Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed