Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794012
• Other study ID #: 15-2288
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: January 5, 2018
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Gingival Diseases
• Inflammation
• Periodontal Disease
• Periodontal Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Rheumatology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines		1 day
Secondary	Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)		1 day
Secondary	Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays		1 day