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Periodontal Disease and Circulatory Microbial Components

Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01154855
Acronym
CirCo
Enrollment
40
Registered
2010-07-01
Start date
2010-01-31
Completion date
2015-05-31
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Disease

Keywords

Periodontal disease, Gum disease, Dental, Inflammation, Microorganisms, Bacteria

Brief summary

The goal of this project is to study the immune activity of certain proteins present in the blood of patients with severe periodontal disease. Periodontal disease (gum disease) is the major cause of tooth loss among adults. Moderate to severe periodontal disease is reported to affect 5-15% of American adults. It begins with an infection of the tissues surrounding the teeth, and leads to a worsening inflammatory response. This study will aid in clarifying the way in which gum disease might affect certain systemic diseases.

Detailed description

This project will have two specific goals: 1. Identify microorganism components in the serum of patients with severe periodontitis; and 2. Characterize the immune regulator activity of periodontitis serum. This proposed feasibility study will then aid in providing the support for an increased sample size and other design requirements for larger, more expanded human clinical trial testing.In this study, forty (40) subjects will be divided into 2 groups: 1) Healthy oral status group and 2) Severe periodontal disease. Patients will be clinically screened using standard periodontal measurements.

Interventions

PROCEDUREProphylaxis ; Gross debridement for diseased patients

1 per patient at 2nd visit lasting approximately 1 hour.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 35 years or older * Healthy patients or patients with severe periodontal disease * Patients with or without Rheumatoid Arthritis * Patients with at least 20 permanent teeth

Exclusion criteria

* Patients undergoing long-term (over 2 weeks) antibiotic-related therapy 3 months prior to study inclusion * Patients receiving periodontal treatment 12 months prior to study inclusion (INCLUDING CLEANINGS) * Patients will be excluded if they receive long-term use of medications known to affect periodontal status such as anti-inflammatory drugs, aspirin and ibuprofen * Patients on immunosuppressive therapies, including glucocorticoids or cyclosporines, are excluded from participation in this study (inhalers are allowed) * History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis * Pregnant women or women attempting to become pregnant

Design outcomes

Primary

MeasureTime frameDescription
Identify microorganism components in the serum of patients with severe periodontitis1hourmicroorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning

Secondary

MeasureTime frameDescription
Characterize the immune regulator activity of periodontitis serum1 hourmicroorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026