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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376791
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : April 23, 2013
Indian Council of Medical Research
University of California, San Diego
Information provided by (Responsible Party):
Roberta A. Gottlieb, San Diego State University

Brief Summary:
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.

Condition or disease
Periodontal Disease Atherosclerosis

Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

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

Biospecimen Retention:   Samples With DNA
Serum, dental scrapings and saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population comprises 200 Native Americans seeking health care at the Indian Health Council.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01376791

United States, California
Indian Health Council
Valley Center, California, United States, 92082
Sponsors and Collaborators
San Diego State University
Indian Council of Medical Research
University of California, San Diego
Principal Investigator: Roberta A Gottlieb, MD San Diego State University

Responsible Party: Roberta A. Gottlieb, Director, SDSU BioScience Center, San Diego State University Identifier: NCT01376791     History of Changes
Other Study ID Numbers: IHC-PDCV
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Roberta A. Gottlieb, San Diego State University:
Periodontal disease
Oral Pathogens
Native Americans
Inflammatory cytokines
Microbial metagenomics

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases