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Periodontal Disease and Circulatory Microbial Components (CirCo)

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ClinicalTrials.gov Identifier: NCT01154855
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
William Giannobile, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment
Periodontal Disease Procedure: Prophylaxis ; Gross debridement for diseased patients

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.
Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis
Study Start Date : January 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Identify microorganism components in the serum of patients with severe periodontitis [ Time Frame: 1hour ]
    microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning


Secondary Outcome Measures :
  1. Characterize the immune regulator activity of periodontitis serum [ Time Frame: 1 hour ]
    microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning


Biospecimen Retention:   Samples With DNA
Dental plaque samples evaluated for microbial DNA

Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
40 adult subjects comprised of two populations: 1) healthy (n=20) and 2) severe periodontal disease (n=20)
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
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Information from the National Library of Medicine

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): NCT01154855


Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: William V Giannobile, DDS, DMedSc University of Michigan
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: William Giannobile, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01154855    
Other Study ID Numbers: HUM00029568
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by William Giannobile, University of Michigan:
Periodontal disease
Gum disease
Dental
 Inflammation
Microorganisms
Bacteria
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases