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

Completed

• Conditions: Periodontal Disease; Atherosclerosis

• Registration Number: NCT01376791
• Lead Sponsor: San Diego State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-19
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Indian Health Council; 🇺🇸 Valley Center, California, United States