Cardiovascular DiseaseNCT00066053
Periodontitis and Cardiovascular Events or "PAVE"
A study testing Periodontal Treatment: SRP and Referral in people with Cardiovascular Disease and Coronary Heart Disease, run by University at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Cardiovascular Disease, Coronary Heart Disease, Myocardial Infarction
- What is being tested?
- Periodontal Treatment: SRP and Referral
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jun 2005
- Phase
- Interventional
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any of the following:
- A major illness requiring hospitalization,
- Renal dialysis,
- Serum creatinine > 3 mg/dl,
- Organ transplant recipient requiring immunosuppression medication,
- Surgery needed in the next 3 years,
Show all 12Show fewer
- Chemotherapy in the past 3 years,
- Head and/or neck radiation at any time in the past,
- Liver dysfunction,
- Class IV congestive heart failure,
- Drug or alcohol abuse,
- Pacemaker or AICD/defibrillator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Intervention for Cardiac Events: A Pilot Trial
The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease.
Read the detailed description
There is growing evidence of a strong association between infection and atherosclerosis as well as a specific link between periodontal infection (gum problems) and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to fewer heart events in persons at high risk for cardiovascular disease. In contrast to previous heart disease studies, the primary treatment in this project is directed toward infectious agents at periodontal sites. This project is a pilot randomized clinical trial to test the feasibility of selecting and refining a periodontal infection treatment and examining the effect of that treatment on future heart events. It is a multi-center planning and pilot study involving five investigational centers at the University at Buffalo (lead and overall coordinating center), University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a data coordinating center at the University of North Carolina. Central microbiology and cytokine laboratories and a biologic specimen bank are also included. A team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers has been assembled to accomplish the research with a careful, cost-effective approach. The ultimate goal is to develop a definitive randomized clinical trial that will include about 4,000 participants from approximately 15 centers across the United States
- Conditions
- Cardiovascular Disease, Coronary Heart Disease, Myocardial Infarction, Cerebrovascular Accident
- Being tested
- Periodontal Treatment: SRP, Referral
- Keywords
- Heart attacks, Stroke, Angina
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Myocardial Infarction, Stroke, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Treatment: SRPProcedure or surgery
Also called Treatment of periodontal infections.
Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions.
ReferralProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Treatment: SRP | Experimental | Comprehensive scaling \& root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions. Receives: Procedure: Periodontal Treatment: SRP |
| Community Comparator | Active comparator | Referral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment. Receives: Procedure: Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startJan 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Sara G Grossi, DDS, MS, Principal investigator, University at BuffaloThomas E van Dyke, DDS,MS, Principal investigator, Goldman School of Dental Medicine, Boston, MAJohn C Gunsolley, DDS,MS, Principal investigator, University of Maryland, Dept. of Periodontics, Baltimore, MDJames D Beck, Ph.D, Principal investigator, University of NC, School of Dentistry, Chapel Hill, NCLloyd E Chambless, PhD,, Principal investigator, University of NC, Dept. of Biostatistics, Chapel Hill, NCSteven Offenbacher, DDS,PhD,MMSc, Principal investigator, University of NC, Comprehensive Cntr. for Inflammatory Diseases, Chapel Hill, NCTheresa Madden, DDS, PhD, Principal investigator, Oregon Health and Science University, Portland, ORGerardo Maupome, PhD, Principal investigator, Kaiser-Permanente Center for Health Research, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066053
- Sponsor's protocol ID
- NIDCR-13940
- Other IDs
- U01DE013940
- Status last verified
- May 2007
- First submitted
- 1 Aug 2003
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Intervention for Cardiac Events: A Pilot Trial
- ClinicalTrials.gov ID
- NCT00066053
- Acronym / sponsor ID
- NIDCR-13940
- Conditions
- Cardiovascular Disease, Coronary Heart Disease, Myocardial Infarction, Cerebrovascular Accident
- Keywords
- Heart attacks, Stroke, Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jan 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 5 Aug 2003 (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.
The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease.
Detailed description
There is growing evidence of a strong association between infection and atherosclerosis as well as a specific link between periodontal infection (gum problems) and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to fewer heart events in persons at high risk for cardiovascular disease. In contrast to previous heart disease studies, the primary treatment in this project is directed toward infectious agents at periodontal sites. This project is a pilot randomized clinical trial to test the feasibility of selecting and refining a periodontal infection treatment and examining the effect of that treatment on future heart events. It is a multi-center planning and pilot study involving five investigational centers at the University at Buffalo (lead and overall coordinating center), University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a data coordinating center at the University of North Carolina. Central microbiology and cytokine laboratories and a biologic specimen bank are also included. A team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers has been assembled to accomplish the research with a careful, cost-effective approach. The ultimate goal is to develop a definitive randomized clinical trial that will include about 4,000 participants from approximately 15 centers across the United States
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal Treatment: SRP | Experimental | Procedure: Periodontal Treatment: SRPComprehensive scaling \& root planing and subgingival tissue removal; fluorides applied as appropriate; oral hygiene instructions. |
| Community Comparator | Active comparator | Procedure: ReferralReferral to community dentist with copy of x-rays and letter with diagnosis and recomendations for treatment. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- A major illness requiring hospitalization,
- Renal dialysis,
- Serum creatinine > 3 mg/dl,
- Organ transplant recipient requiring immunosuppression medication,
- Surgery needed in the next 3 years,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal Treatment: SRPAlso: Treatment of periodontal infections.Scaling and root planing. Subgingival tissue removal. Fluorides as needed. Oral hygiene instructions. Oral hygiene instructions. | Procedure or surgery | Periodontal Treatment: SRP |
| Referral | Procedure or surgery | Community Comparator |
Primary outcome
Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke.
Time frame: One year
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 5 Aug 2011.
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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.
Sara G Grossi, DDS, MS principal investigator
University at Buffalo
Thomas E van Dyke, DDS,MS principal investigator
Goldman School of Dental Medicine, Boston, MA
John C Gunsolley, DDS,MS principal investigator
University of Maryland, Dept. of Periodontics, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Treatment: SRP and Referral in people with Cardiovascular Disease and Coronary Heart Disease, run by University at Buffalo 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 0 inclusion and 12 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 5 Aug 2011. 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?
Patient outcomes are hospitalized for myocardial infarction (MI), cardiac revascularization, fatal coronary heart disease, unstable angina, and/or hospitalized ischemic stroke. (time frame: One year). 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 5 Aug 2011.