Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults

Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.

We propose to examine a population of Native Americans who have had little or no dental care, and to determine if periodontal disease is associated with early signs of vascular dysfunction or systemic inflammation. We then propose to treat the periodontitis and re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated with vascular function.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Periodontal Disease

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• United States
  • California
    • Valley Center, California, United States, 92082
      • Indian Health Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population comprises 200 Native Americans seeking health care at the Indian Health Council.

Description

Inclusion Criteria:

• American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
• Males and females aged 21-40 years.

Exclusion criteria:

• Recent (within 6 months) periodontal treatment
• History of high blood pressure or existing heart disease
• Xerostomia
• Currently receiving treatment for cancer
• Currently taking anti-inflammatory medications (except H2 blockers, statins, or medications that can affect periodontal status
• Immunosuppressed due to medication or HIV infection, or presence of active infection such as hepatitis or tuberculosis
• Fewer than 20 teeth in functional dentition, excluding third molars, or other gross oral pathology

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of bacterial populations in periodontal samples before and after standard periodontal treatment, stratified by severity of gum disease, using microbial metagenomics analysis.	The study will assess if periodontal bacterial flora differ in patients with healthy gums, mild, or severe periodontal disease.	Time of enrollment and at 6 week follow up visit

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: University of California, San Diego; Indian Council of Medical Research
• Investigators: Principal Investigator: Roberta A Gottlieb, MD, San Diego State University

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (Estimate): June 20, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Atherosclerosis; Native Americans; Periodontal disease; Oral Pathogens; Inflammatory cytokines; Microbial metagenomics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Mouth Diseases; Atherosclerosis; Periodontal Diseases
• Other Study ID Numbers: IHC-PDCV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No