Clinical trial NCT01154855: Periodontal Disease and Circulatory Microbial Components
Official title: Circulatory Microbial Components and Immune Regulators of Patients With Periodontal Disease and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Keywords: Periodontal disease
Gum disease
Dental
Inflammation
Microorganisms
Bacteria
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 adult subjects comprised of two populations: 1) healthy (n=20) and 2) severe periodontal disease (n=20)

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.

Eligibility 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

Primary outcomes:
measure: Identify microorganism components in the serum of patients with severe periodontitis
timeFrame: 1hour
Secondary outcomes:
measure: Characterize the immune regulator activity of periodontitis serum
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: William V Giannobile, DDS, DMedSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.