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Completed

NCT Number: NCT01154855

Periodontal Disease and Circulatory Microbial Components

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylaxis ; Gross debridement for diseased patients

Procedure

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

Other names: Teeth cleaning

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: CirCo

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2010
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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