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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376791
• Other study ID #: IHC-PDCV
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: April 19, 2013
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Locations

Country	Name	City	State
United States	Indian Health Council	Valley Center	California

Sponsors (3)

Lead Sponsor	Collaborator
San Diego State University	Indian Council of Medical Research, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of bacterial populations in periodontal samples before and after standard periodontal treatment, stratified by severity of gum disease, using microbial metagenomics analysis.	The study will assess if periodontal bacterial flora differ in patients with healthy gums, mild, or severe periodontal disease.	Time of enrollment and at 6 week follow up visit	No