Periodontal Disease and Circulatory Microbial Components

Periodontal Disease Clinical Trial

— CirCo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154855
• Other study ID #: HUM00029568
• Status: Completed
• Phase: Phase 0
• First received: March 16, 2010
• Last updated: December 11, 2015
• Start date: January 2010
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Procedure:
• Prophylaxis ; Gross debridement for diseased patients
1 per patient at 2nd visit lasting approximately 1 hour.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

References & Publications (6)

Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. Review. — View 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. — View 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. Epub 2006 Aug 10. — View 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. — View Citation

Marchesan J, Jiao YZ, 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. 201 — View Citation

Pussinen PJ, Paju S, Mäntylä P, Sorsa T. Serum microbial- and host-derived markers of periodontal diseases: a review. Curr Med Chem. 2007;14(22):2402-12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify microorganism components in the serum of patients with severe periodontitis	microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning	1hour	No
Secondary	Characterize the immune regulator activity of periodontitis serum	microorganism components will be analyzed in serum samples collected before teeth cleaning and again 5 minutes after teeth cleaning	1 hour	No

External Links

•   MCOHR study information for patients
•   University of Michigan clinical research database for patients