Periodontal DiseasesNCT03042117
Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body
An observational study of Periodontal Diseases and Cardiovascular Diseases, run by Texas Tech University Health Sciences Center.
Trial summary
Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Cardiovascular Diseases
- What is being tested?
- periodontal probing
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2016to 13 Jul 2017
- 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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients from ages 18-89 years who are being seen in the Center for Cardiovascular Health at TTUHSC and at Dr. Johnson's dental clinic who meet the inclusion criteria, and who will consent to participating in the study. There will be between 25 to 35 patients in each group.
Who may be able to join
- Patients with known CAD with previous MI, OR
- Patients without known CAD
- Ages 18-89 years
- Patients who have dental implants with a recorded patient history of how the teeth were lost
- Patients with at least one tooth in each of the four quadrants of the mouth
- Able to obtain all necessary pocket measurements and blood samples needed for the study
Who cannot join
- Patients with a known history of rheumatoid arthritis
- Patients with a known history of lupus
- Patients currently under the care of a rheumatologist
- Patients who have had a MI in the two weeks prior to entering the study
- Patients with a previous history of coronary artery bypass graft
- Current smokers and tobacco users
- Patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10. Patients who have undergone chemotherapy in the past five years
- Patients who currently use steroids or immunosuppressive agents
About this study
Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. Inflammation is a driving force in both of these diseases, creating a potential bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. In this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. A definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.
Read the detailed description
Dental probes will be used to probe depth of gum recession in subjects with and without a history of cardiac events. Venous blood samples will also be collected from all subjects for measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will then be done, in attempt to identify a difference in gum recession depth and/or serum inflammatory markers among those with and without prior cardiac events.
- Conditions
- Periodontal Diseases, Cardiovascular Diseases
- Being tested
- periodontal probing
- Medical subject headings
- Periodontal Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal probingOther
A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects
| Study group | Role | What they receive |
|---|---|---|
| No Coronary Artery Disease (CAD) | Patients with no known cardiovascular disease. Receives: Other: periodontal probing | |
| CAD without Myocardial Infarction (MI) | Patients with cardiovascular disease without a myocardial infarction. Receives: Other: periodontal probing | |
| CAD with MI | Patients with cardiovascular disease with previous history of a myocardial infarction. Receives: Other: periodontal probing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of periodontal disease
Measured: one day
Secondary outcomes (4)
ESR
Measured: one day
Myeloperoxidase (MPO)
Measured: one day
IgG
Measured: one day
hs-CRP
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start18 Oct 2016
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Why it stopped: Insufficient funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ami Knox, MBA, Study director, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042117
- Sponsor's protocol ID
- L17-008
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Individual data sharing
- No: Data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body
- ClinicalTrials.gov ID
- NCT03042117
- Acronym / sponsor ID
- L17-008
- Conditions
- Periodontal Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 3 Feb 2017 (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.
Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. Inflammation is a driving force in both of these diseases, creating a potential bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. In this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. A definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.
Detailed description
Dental probes will be used to probe depth of gum recession in subjects with and without a history of cardiac events. Venous blood samples will also be collected from all subjects for measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will then be done, in attempt to identify a difference in gum recession depth and/or serum inflammatory markers among those with and without prior cardiac events.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Coronary Artery Disease (CAD) | – | Other: periodontal probingPatients with no known cardiovascular disease. |
| CAD without Myocardial Infarction (MI) | – | Other: periodontal probingPatients with cardiovascular disease without a myocardial infarction. |
| CAD with MI | – | Other: periodontal probingPatients with cardiovascular disease with previous history of a myocardial infarction. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients from ages 18-89 years who are being seen in the Center for Cardiovascular Health at TTUHSC and at Dr. Johnson's dental clinic who meet the inclusion criteria, and who will consent to participating in the study. There will be between 25 to 35 patients in each group.
Key inclusion criteria (6 listed)
- Patients with known CAD with previous MI, OR
- Patients without known CAD
- Ages 18-89 years
- Patients who have dental implants with a recorded patient history of how the teeth were lost
- Patients with at least one tooth in each of the four quadrants of the mouth
Key exclusion criteria (8 listed)
- Patients with a known history of rheumatoid arthritis
- Patients with a known history of lupus
- Patients currently under the care of a rheumatologist
- Patients who have had a MI in the two weeks prior to entering the study
- Patients with a previous history of coronary artery bypass graft
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 probingA periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects | Other | CAD with MI, CAD without Myocardial Infarction (MI), No Coronary Artery Disease (CAD) |
Primary outcome
Level of periodontal disease
Time frame: one day
4 secondary outcomes
ESR
Time frame: one day
Myeloperoxidase (MPO)
Time frame: one day
IgG
Time frame: one day
hs-CRP
Time frame: one day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers
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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.
Ami Knox, MBA study director
Texas Tech University Health Sciences Center
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Cardiovascular Diseases, run by Texas Tech University Health Sciences Center.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Level of periodontal disease (time frame: one day). 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 30 Jan 2020.