Periodontal Disease and Circulatory Microbial Components (CirCo)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William Giannobile, University of Michigan
ClinicalTrials.gov Identifier:
NCT01154855
First received: March 16, 2010
Last updated: June 13, 2014
Last verified: June 2014
  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.


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


Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Periodontitis

Patients with severe periodontal disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients

Other Names:

Teeth cleaning

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

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 Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients

Other Names:

Teeth cleaning

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, 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154855

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, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01154855     History of Changes
Other Study ID Numbers: HUM00029568
Study First Received: March 16, 2010
Last Updated: June 13, 2014
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:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014