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Periodontal Disease and Circulatory Microbial Components

NCT ID: NCT01154855

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Periodontal Disease

Keywords

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Periodontal disease Gum disease Dental Inflammation Microorganisms Bacteria

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Prophylaxis ; Gross debridement for diseased patients

Intervention Type PROCEDURE

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

Healthy patients

Patients without periodontal (gum) disease Intervention (Procedure/surgery): Prophylaxis; Gross debridement for diseased patients

Other Names:

Teeth cleaning

Prophylaxis ; Gross debridement for diseased patients

Intervention Type PROCEDURE

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

Interventions

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Prophylaxis ; Gross debridement for diseased patients

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

Intervention Type PROCEDURE

Other Intervention Names

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Teeth cleaning

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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William Giannobile

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William V Giannobile, DDS, DMedSc

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Countries

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United States

References

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Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. doi: 10.1016/j.cell.2006.02.015.

Reference Type BACKGROUND
PMID: 16497588 (View on PubMed)

Forner L, Nielsen CH, Bendtzen K, Larsen T, Holmstrup P. Increased plasma levels of IL-6 in bacteremic periodontis patients after scaling. J Clin Periodontol. 2006 Oct;33(10):724-9. doi: 10.1111/j.1600-051X.2006.00964.x. Epub 2006 Aug 10.

Reference Type BACKGROUND
PMID: 16901299 (View on PubMed)

D'Aiuto F, Parkar M, Andreou G, Suvan J, Brett PM, Ready D, Tonetti MS. Periodontitis and systemic inflammation: control of the local infection is associated with a reduction in serum inflammatory markers. J Dent Res. 2004 Feb;83(2):156-60. doi: 10.1177/154405910408300214.

Reference Type BACKGROUND
PMID: 14742655 (View on PubMed)

Garlet GP, Martins W Jr, Ferreira BR, Milanezi CM, Silva JS. Patterns of chemokines and chemokine receptors expression in different forms of human periodontal disease. J Periodontal Res. 2003 Apr;38(2):210-7. doi: 10.1034/j.1600-0765.2003.02012.x.

Reference Type BACKGROUND
PMID: 12608917 (View on PubMed)

Pussinen PJ, Paju S, Mantyla P, Sorsa T. Serum microbial- and host-derived markers of periodontal diseases: a review. Curr Med Chem. 2007;14(22):2402-12. doi: 10.2174/092986707781745604.

Reference Type BACKGROUND
PMID: 17896988 (View on PubMed)

Marchesan J, Jiao Y, Schaff RA, Hao J, Morelli T, Kinney JS, Gerow E, Sheridan R, Rodrigues V, Paster BJ, Inohara N, Giannobile WV. TLR4, NOD1 and NOD2 mediate immune recognition of putative newly identified periodontal pathogens. Mol Oral Microbiol. 2016 Jun;31(3):243-258. doi: 10.1111/omi.12116. Epub 2015 Sep 10.

Reference Type RESULT
PMID: 26177212 (View on PubMed)

Other Identifiers

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HUM00029568

Identifier Type: -

Identifier Source: org_study_id