Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

Completed

• Conditions: Periodontal Disease; Rheumatoid Arthritis

• Registration Number: NCT02794012
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Study Start: 2016-07
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines	1 day

Secondary Outcome Measures

Name	Time	Method
Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)	1 day
Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays	1 day

Trial Locations

Locations (1)

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States