Periodontal Disease and Circulatory Microbial Components (CirCo)

December 11, 2015 updated by: William Giannobile, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

40 adult subjects comprised of two populations: 1) healthy (n=20) and 2) severe periodontal disease (n=20)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Teeth cleaning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 11, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00029568

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontal Disease

Clinical Trials on Prophylaxis ; Gross debridement for diseased patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe