Assess the Effect of Treating Periodontal Disease on Card... | NCT01376791

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

NCT01376791

Sponsor

San Diego State University

Status

Completed

Last Update Posted

Apr 23, 2013Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Periodontal Disease
Atherosclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jun 17, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2013

Last Update Posted Date

Apr 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Roberta A. Gottlieb, Director, SDSU BioScience Center, San Diego State UniversityPrincipal Investigator

Lead Sponsor

San Diego State UniversityOTHER

Collaborators

Name	Class
Indian Council of Medical Research	OTHER_GOV
University of California, San Diego	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

92Actual

Outcomes Module

Primary Outcomes

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.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberta A Gottlieb, MD	San Diego State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indian Health Council		Valley Center	California	92082	United States

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided