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

This study has been completed.
Sponsor:
Collaborators:
Indian Council of Medical Research
University of California, San Diego
Information provided by (Responsible Party):
Roberta A. Gottlieb, San Diego State University
ClinicalTrials.gov Identifier:
NCT01376791
First received: June 17, 2011
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Periodontal Disease
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 92
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376791

Locations
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
Investigators
Principal Investigator: Roberta A Gottlieb, MD San Diego State University
  More Information

No publications provided

Responsible Party: Roberta A. Gottlieb, Director, SDSU BioScience Center, San Diego State University
ClinicalTrials.gov Identifier: NCT01376791     History of Changes
Other Study ID Numbers: IHC-PDCV
Study First Received: June 17, 2011
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Periodontal disease
Atherosclerosis
Oral Pathogens
 Native Americans
Inflammatory cytokines
Microbial metagenomics

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

ClinicalTrials.gov processed this record on May 16, 2013