Periodontal Disease and Circulatory Microbial Components (CirCo)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Michigan.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Michigan
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01154855
First received: March 16, 2010
Last updated: October 25, 2010
Last verified: January 2010
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Purpose
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, such as rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Periodontal Disease |
Procedure: Prophylaxis ; Gross debridement for diseased patients |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- Identify microorganism components in the serum of patients with severe periodontitis [ Time Frame: 1hour ] [ Designated as safety issue: No ]microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning
Secondary Outcome Measures:
- Characterize the immune regulator activity of periodontitis serum [ Time Frame: 1 hour ] [ Designated as safety issue: No ]microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Periodontitis
Patients with severe periodontal disease
|
Procedure: Prophylaxis ; Gross debridement for diseased patients
1 per patient at 2nd visit lasting approximately 1 hour.
Other Name: Teeth cleaning
|
|
Experimental: Healthy patients
Patients without periodontal (gum) disease
|
Procedure: Prophylaxis ; Gross debridement for diseased patients
1 per patient at 2nd visit lasting approximately 1 hour.
Other Name: Teeth cleaning
|
|
Experimental: Rheumatoid Arthritis Patients with Severe Periodontal Disease
Patients with Rheumatoid Arthritis & severe periodontal disease
|
Procedure: Prophylaxis ; Gross debridement for diseased patients
1 per patient at 2nd visit lasting approximately 1 hour.
Other Name: Teeth cleaning
|
|
Experimental: Rheumatoid Arthritis Patients with Healthy gums
Rheumatoid Arthritis Patients without Gum Disease
|
Procedure: Prophylaxis ; Gross debridement for diseased patients
1 per patient at 2nd visit lasting approximately 1 hour.
Other Name: Teeth cleaning
|
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, eighty (80) subjects will be divided into 4 groups: 1) Healthy oral status group; 2) Severe periodontal disease; 3) Healthy oral status group WITH RHEUMATOID ARTHRITIS; 4)Severe periodontal disease WITH RHEUMATOID ARTHRITIS. Patients will be clinically screened using standard periodontal measurements.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154855
Contacts
| Contact: Lea M Franco, MS, BS | 734-998-6721 | mcohrclinicalresearch@umich.edu |
| Contact: Anna M Galloro, BS, MT | 734-998-6721 | mcohrclinicalresearch@umich.edu |
Locations
| United States, Michigan | |
| Michigan Center for Oral Health Research (MCOHR) | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Lea M Franco, MS, BS 734-998-6721 mcohrclinicalresearch@umich.edu | |
| Contact: Anna M Galloro, BS, MT 734-998-6721 mcohrclinicalresearch@umich.edu | |
| Principal Investigator: William V Giannobile, DDS, DMedSc | |
| Sub-Investigator: Julie T Marchesan, DDS | |
| Sub-Investigator: Thiago Morelli, DDS, MS | |
| Sub-Investigator: Janet Kinney, RDH, MS, MS | |
Sponsors and Collaborators
University of Michigan
Investigators
| Principal Investigator: | William V Giannobile, DDS, DMedSc | University of Michigan |
More Information
Additional Information:
Publications:
| Responsible Party: | William Giannobile, University of Michigan School of Dentistry - Periodontics and Oral Medicine |
| ClinicalTrials.gov Identifier: | NCT01154855 History of Changes |
| Other Study ID Numbers: | HUM00029568 |
| Study First Received: | March 16, 2010 |
| Last Updated: | October 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Periodontal disease Gum disease Dental |
Inflammation Microorganisms Bacteria |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Periodontal Diseases Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013