Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT02794012 |
Recruitment Status :
Completed
First Posted : June 8, 2016
Last Update Posted : January 9, 2018
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Condition or disease |
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Rheumatoid Arthritis Periodontal Disease |
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 |

Group/Cohort |
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At-Risk Rheumatoid Arthritis subjects |
Early Rheumatoid Arthritis subjects |
Healthy Controls |
Non-Rheumatoid Arthritis Autoimmune Controls |
- Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines [ Time Frame: 1 day ]
- 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 ]

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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 |
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

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
United States, Colorado | |
Barbara Davis Center | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Lindsay B Kelmenson, MD | University of Colorado, Denver |
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 |
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 |