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

NCT ID: NCT01376791

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Disease Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indian Council of Medical Research

OTHER_GOV

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role lead

Responsible Party

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Roberta A. Gottlieb

Director, SDSU BioScience Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberta A Gottlieb, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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Indian Health Council

Valley Center, California, United States

Site Status

Countries

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United States

Other Identifiers

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IHC-PDCV

Identifier Type: -

Identifier Source: org_study_id

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