AtherosclerosisNCT02977351
Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms
A study testing Non-surgical periodontal treatment in people with Atherosclerosis and Chronic Periodontitis, run by Izmir Katip Celebi University.
Trial summary
Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Chronic Periodontitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- had no systemic disease,
- had not used any antibiotics
- had not used medications with an impact on the immune system,
- had not received any periodontal and/or medical treatment within the last 6 months.
Who cannot join
- smokers of cigarettes or other tobacco products,
- pregnant or breastfeeding,
- non-stable cardiovascular condition.
About this study
Official title: Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients
Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
Read the detailed description
It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.
- Conditions
- Atherosclerosis, Chronic Periodontitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Periodontopathogenic microorganisms, Non-surgical periodontal treatment
- Medical subject headings
- Atherosclerosis, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Atherosclerosis | Experimental | Patients with atherosclerosis and chronic periodontitis Receives: Procedure: Non-surgical periodontal treatment |
| Systemically healthy | Active comparator | Patients with Systemically healthy and chronic periodontitis. Receives: Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontopathogenic microorganism levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Seckin ERTUGRUL, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977351
- Sponsor's protocol ID
- IzmirKCU
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT02977351
- Acronym / sponsor ID
- IzmirKCU
- Conditions
- Atherosclerosis, Chronic Periodontitis
- Keywords
- Periodontopathogenic microorganisms, Non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Nov 2016 (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.
Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
Detailed description
It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atherosclerosis | Experimental | Procedure: Non-surgical periodontal treatmentPatients with atherosclerosis and chronic periodontitis |
| Systemically healthy | Active comparator | Procedure: Non-surgical periodontal treatmentPatients with Systemically healthy and chronic periodontitis. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- had no systemic disease,
- had not used any antibiotics
- had not used medications with an impact on the immune system,
- had not received any periodontal and/or medical treatment within the last 6 months.
Key exclusion criteria (3 listed)
- smokers of cigarettes or other tobacco products,
- pregnant or breastfeeding,
- non-stable cardiovascular condition.
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 |
|---|---|---|
| Non-surgical periodontal treatment | Procedure or surgery | Atherosclerosis, Systemically healthy |
Primary outcome
Periodontopathogenic microorganism levels
Time frame: 1 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 30 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Atherosclerosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Atherosclerosis and Chronic Periodontitis, run by Izmir Katip Celebi University.
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 4 inclusion and 3 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 30 Nov 2016. 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 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?
Periodontopathogenic microorganism levels (time frame: 1 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 30 Nov 2016.