Cardiovascular DiseaseNCT00093236
Impact of Gum Infection on Heart Disease
A study testing Early Periodontal Treatment and Usual Dental Hygiene in people with Cardiovascular Disease and Periodontal Disease, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Periodontal Disease
- What is being tested?
- Early Periodontal Treatment and Usual Dental Hygiene
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to 8 Dec 2012
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
- In this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.
Who cannot join
- Known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
- Major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the ATP-III guidelines.
- Other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including HIV and hepatitis C infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
- Use of antibiotics within three months.
- Use of oral contraceptives or hormone replacement therapy.
- Major psychiatric illness requiring treatment or that might interfere with the ability to understand and cooperate with the protocol.
Show all 12Show fewer
- Ongoing drug or alcohol abuse.
- Use of sildenafil (Viagra) within 7 days because of the risk of marked hypotension with nitroglycerin administration.
- History of migraine headaches that might be exacerbated by nitroglycerin.
- Use of cholesterol lowering therapy, angiotensin converting enzyme inhibitors (subjects should not be taking these drugs because they will have no history of cardiovascular disease risk factors).
- Antioxidant vitamins (vitamin C or vitamin E) in doses exceeding the Recommended Dietary Allowances (RDA), (60 mg/day and 30 IU/day, respectively).
- Pregnancy, as diagnosed by serum beta-hCG.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Campus
Boston, Massachusetts, 02118
About this study
Official title: Systemic Endothelial Consequences of Periodontal Disease
The purpose of this study is to determine the effect of gum infection on parameters of cardio-vascular disease.
Read the detailed description
Epidemiological studies indicate that individuals with severe periodontal disease have significantly increased risk for cardiovascular disease. Periodontal disease, a chronic bacterial infection of the gums, is associated with recurrent bacteremia and a state of systemic inflammation that may convert endothelial cells to a pro-atherogenic phenotype with increased expression of inflammatory factors and loss of the anti-thrombotic, growth inhibitory, and vasodilator properties of the endothelium, including a decrease in the biological activity of nitric oxide. In human subjects, endothelial dysfunction has evolved into a well-accepted indicator of early atherosclerosis and predictor of increased cardiovascular disease risk. We have recently demonstrated a strong association between severe periodontal disease and endothelial vasomotor dysfunction in a case control study of otherwise healthy human subjects. In that study, periodontal disease was also associated with higher plasma levels of the acute phase reactant C-reactive protein (CRP). These results support the hypothesis that severe periodontal disease induces a state of systemic inflammation that impairs endothelial function, however, the cross-sectional design leaves open the possibility that confounding factors explain the results. We now propose to determine whether effective treatment of periodontal disease improves endothelial function (Aim 1) and reduces inflammation (Aim 2) in a randomized intervention study. Patients will receive comprehensive periodontal treatment designed to produce a state of periodontal health (scaling and root planing and periodontal surgery with re-treatment as needed) or routine oral hygiene and will be followed for 24 weeks. The study will examine endothelium-dependent brachial artery flow-mediated dilation, systemic markers of inflammation and endothelial activation (CRP, IL-6, myeloperoxidase, and ICAM-1), and oral markers of periodontitis (PGE2, myeloperoxidase, and pathogen DNA) before and after treatment. Compared to oral hygiene (which will stabilize, but not reverse periodontal disease), we hypothesize that comprehensive treatment of periodontal disease will improve endothelium-dependent dilation and reduce local and systemic inflammation. Further, we suggest that the degree of improvement in endothelial function will relate to the degree of reduction in specific markers of inflammation. Such results would provide much stronger evidence for causal links between periodontal disease, systemic inflammation, and endothelial dysfunction, a recognized surrogate for cardiovascular risk. The proposed studies will provide new insights into how periodontal disease contributes to cardiovascular disease risk in human subjects and may lead to new approaches to therapy.
- Conditions
- Cardiovascular Disease, Periodontal Disease
- Being tested
- Early Periodontal Treatment, Usual Dental Hygiene
- Medical subject headings
- Cardiovascular Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Periodontal TreatmentProcedure or surgery
Subjects will receive scaling and root planing at baseline. Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health.comprehensive periodontal treatment
Usual Dental HygieneProcedure or surgery
Subjects will receive routine oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Early Periodontal Treatment | Experimental | Subjects will receive scaling, root planing and if needed periodontal surgery Receives: Procedure: Early Periodontal Treatment |
| Usual Dental Hygiene | Active comparator | Subjects will receive routine oral hygiene Receives: Procedure: Usual Dental Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal disease progression
Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health. During this period, the Usual Hygiene Group will return for oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.
Measured: 3 wks, 12 wks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionApr 2011
- Study completion8 Dec 2012
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.
- More trials run by Boston 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Salomon Amar, DMD, Ph.D, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093236
- Sponsor's protocol ID
- H-23262
- Other IDs
- R01DE015345
- Status last verified
- Apr 2017
- First submitted
- 5 Oct 2004
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Endothelial Consequences of Periodontal Disease
- ClinicalTrials.gov ID
- NCT00093236
- Acronym / sponsor ID
- H-23262
- Conditions
- Cardiovascular Disease, Periodontal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Sep 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- 8 Dec 2012 (actual)
- First posted
- 7 Oct 2004 (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 the effect of gum infection on parameters of cardio-vascular disease.
Detailed description
Epidemiological studies indicate that individuals with severe periodontal disease have significantly increased risk for cardiovascular disease. Periodontal disease, a chronic bacterial infection of the gums, is associated with recurrent bacteremia and a state of systemic inflammation that may convert endothelial cells to a pro-atherogenic phenotype with increased expression of inflammatory factors and loss of the anti-thrombotic, growth inhibitory, and vasodilator properties of the endothelium, including a decrease in the biological activity of nitric oxide. In human subjects, endothelial dysfunction has evolved into a well-accepted indicator of early atherosclerosis and predictor of increased cardiovascular disease risk. We have recently demonstrated a strong association between severe periodontal disease and endothelial vasomotor dysfunction in a case control study of otherwise healthy human subjects. In that study, periodontal disease was also associated with higher plasma levels of the acute phase reactant C-reactive protein (CRP). These results support the hypothesis that severe periodontal disease induces a state of systemic inflammation that impairs endothelial function, however, the cross-sectional design leaves open the possibility that confounding factors explain the results. We now propose to determine whether effective treatment of periodontal disease improves endothelial function (Aim 1) and reduces inflammation (Aim 2) in a randomized intervention study. Patients will receive comprehensive periodontal treatment designed to produce a state of periodontal health (scaling and root planing and periodontal surgery with re-treatment as needed) or routine oral hygiene and will be followed for 24 weeks. The study will examine endothelium-dependent brachial artery flow-mediated dilation, systemic markers of inflammation and endothelial activation (CRP, IL-6, myeloperoxidase, and ICAM-1), and oral markers of periodontitis (PGE2, myeloperoxidase, and pathogen DNA) before and after treatment. Compared to oral hygiene (which will stabilize, but not reverse periodontal disease), we hypothesize that comprehensive treatment of periodontal disease will improve endothelium-dependent dilation and reduce local and systemic inflammation. Further, we suggest that the degree of improvement in endothelial function will relate to the degree of reduction in specific markers of inflammation. Such results would provide much stronger evidence for causal links between periodontal disease, systemic inflammation, and endothelial dysfunction, a recognized surrogate for cardiovascular risk. The proposed studies will provide new insights into how periodontal disease contributes to cardiovascular disease risk in human subjects and may lead to new approaches to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Periodontal Treatment | Experimental | Procedure: Early Periodontal TreatmentSubjects will receive scaling, root planing and if needed periodontal surgery |
| Usual Dental Hygiene | Active comparator | Procedure: Usual Dental HygieneSubjects will receive routine oral hygiene |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The study seeks to enroll patients with periodontal disease and no other major co-morbidities including cardiovascular disease or other major medical problems.
- In this intervention study, cigarette smokers will be permitted as justified below and randomized in stratified fashion to ensure equal numbers in the two treatment groups.
Key exclusion criteria (12 listed)
- Known cardiovascular disease including coronary heart disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure.
- Major coronary risk factors including diabetes mellitus, hypertension, hypercholesterolemia requiring treatment according to the ATP-III guidelines.
- Other major illness including cancer, liver disease, renal disease, pulmonary disease, chronic infectious disease (including HIV and hepatitis C infection), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy.
- Use of antibiotics within three months.
- Use of oral contraceptives or hormone replacement therapy.
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 |
|---|---|---|
| Early Periodontal TreatmentSubjects will receive scaling and root planing at baseline. Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health.comprehensive periodontal treatment | Procedure or surgery | Early Periodontal Treatment |
| Usual Dental HygieneSubjects will receive routine oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation. | Procedure or surgery | Usual Dental Hygiene |
Primary outcome
Periodontal disease progression
Time frame: 3 wks, 12 wks, and 24 weeks
Three weeks after initiation of the study, they will return and be re-evaluated for the need for periodontal surgery. If indicated, they will then receive definitive periodontal surgery over the next 4 weeks. At the 12-week time point, periodontal surgery will be reevaluated and further therapy provided as needed and make repeated visits as needed to achieve periodontal health. During this period, the Usual Hygiene Group will return for oral hygiene visits at the 3 and 12-week time points. After a 12-week period (24 week time point) to allow healing and resolution of a systemic inflammatory state, patients will return for follow-up measurements of periodontal parameters, vascular function and inflammation.
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 20 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Salomon Amar, DMD, Ph.D principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Periodontal Treatment and Usual Dental Hygiene in people with Cardiovascular Disease and Periodontal Disease, run by Boston 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 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 20 Apr 2017. 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?
Periodontal disease progression (time frame: 3 wks, 12 wks, and 24 weeks). 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 20 Apr 2017.