Periodontal Disease and Circulatory Microbial Components

NCT01154855 | Completed DMC

• 1 other identifier: HUM00029568
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Disease

Keywords

Periodontal disease; Gum disease; Dental; Inflammation; Microorganisms; Bacteria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Characterize the immune regulator activity of periodontitis serum

  1 hour

Study Arms (2)

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

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

Interventions

Prophylaxis ; Gross debridement for diseased patients PROCEDURE

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

Also known as: Teeth cleaning

Healthy patients; Periodontitis

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years or older
• Healthy patients or patients with severe periodontal disease
• Patients with or without Rheumatoid Arthritis
• Patients with at least 20 permanent teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Related Publications (6)

• 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.

  PMID: 16497588 BACKGROUND

• 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.

  PMID: 16901299 BACKGROUND

• 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.

  PMID: 14742655 BACKGROUND

• 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.

  PMID: 12608917 BACKGROUND

• 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.

  PMID: 17896988 BACKGROUND

• 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.

  PMID: 26177212 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Dental plaque samples evaluated for microbial DNA

MeSH Terms

Conditions

Periodontal Diseases; Gingival Diseases; Inflammation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William V Giannobile, DDS, DMedSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: July 1, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12