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
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01154855
First received: March 16, 2010
Last updated: October 25, 2010
Last verified: January 2010
  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 April 16, 2014