Periodontal DiseaseNCT01376791
Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults
An observational study of Periodontal Disease and Atherosclerosis, run by San Diego State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Atherosclerosis
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population comprises 200 Native Americans seeking health care at the Indian Health Council.
Who may be able to join
- American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
- Males and females aged 21-40 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indian Health Council
Valley Center, California, 92082
About this study
Official title: 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.
- Conditions
- Periodontal Disease, Atherosclerosis
- Keywords
- Periodontal disease, Atherosclerosis, Oral Pathogens, Native Americans, Inflammatory cytokines, Microbial metagenomics
- Medical subject headings
- Periodontal Diseases, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time of enrollment and at 6 week follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research, University of California, San Diego
- Responsible party
- Principal investigator, Roberta A. Gottlieb, San Diego State University
- Investigators
- Roberta A Gottlieb, MD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376791
- Sponsor's protocol ID
- IHC-PDCV
- Status last verified
- Apr 2013
- First submitted
- 17 Jun 2011
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Flora, Periodontitis, and Vascular Dysfunction in Young Native Americans.
- ClinicalTrials.gov ID
- NCT01376791
- Acronym / sponsor ID
- IHC-PDCV
- Conditions
- Periodontal Disease, Atherosclerosis
- Keywords
- Periodontal disease, Atherosclerosis, Oral Pathogens, Native Americans, Inflammatory cytokines, Microbial metagenomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research, University of California, San Diego
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population comprises 200 Native Americans seeking health care at the Indian Health Council.
Key inclusion criteria (2 listed)
- American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
- Males and females aged 21-40 years.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta A Gottlieb, MD principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Disease and Atherosclerosis, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.