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

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.

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Key information

Conditions

Periodontal Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases Vascular Diseases

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Indian Health Council

Valley Center, California, 92082, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

Indian Council of Medical Research
University of California, San Diego

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jun 20, 2011
Registry last updated: Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed