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

NCT01376791 | Completed

• 1 other identifier: IHC-PDCV
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease; Atherosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population comprises 200 Native Americans seeking health care at the Indian Health Council.

You may qualify if:

• American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
• Males and females aged 21-40 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• Indian Council of Medical Research: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Indian Health Council

Valley Center, California, 92082, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, dental scrapings and saliva

MeSH Terms

Conditions

Periodontal Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Roberta A Gottlieb, MD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, SDSU BioScience Center

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 20, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)