Periodontal Disease and Circulatory Microbial Components

Completed

• Conditions: Periodontal Disease
• Interventions: Procedure: Prophylaxis ; Gross debridement for diseased patients

• Registration Number: NCT01154855
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy patients	Prophylaxis ; Gross debridement for diseased patients	Patients without periodontal (gum) disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients Other Names: Teeth cleaning
Periodontitis	Prophylaxis ; Gross debridement for diseased patients	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.

Primary Outcome Measures

Name	Time	Method
Identify microorganism components in the serum of patients with severe periodontitis	1hour	microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning

Secondary Outcome Measures

Name	Time	Method
Characterize the immune regulator activity of periodontitis serum	1 hour	microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning