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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01376791

Enrollment

Registered

2011-06-20

Start date

2010-12-31

Completion date

2012-12-31

Last updated

2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Periodontal Disease

Keywords

Periodontal disease, Atherosclerosis, Oral Pathogens, Native Americans, Inflammatory cytokines, Microbial metagenomics

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Determination of bacterial populations in periodontal samples before and after standard periodontal treatment, stratified by severity of gum disease, using microbial metagenomics analysis.	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.

Countries

United States

Outcome results