- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376791
Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults
April 19, 2013 updated by: Roberta A. Gottlieb, San Diego State University
Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Valley Center, California, United States, 92082
- Indian Health Council
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population comprises 200 Native Americans seeking health care at the Indian Health Council.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of bacterial populations in periodontal samples before and after standard periodontal treatment, stratified by severity of gum disease, using microbial metagenomics analysis.
Time Frame: 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.
|
Time of enrollment and at 6 week follow up visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roberta A Gottlieb, MD, San Diego State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (Estimate)
June 20, 2011
Study Record Updates
Last Update Posted (Estimate)
April 23, 2013
Last Update Submitted That Met QC Criteria
April 19, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHC-PDCV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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