Myocardial InfarctionNCT03005886
The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
A study testing Periodontal examination, GCF sampling and phase I therapy in people with Myocardial Infarction and Chronic Periodontitis, run by Gazi University.
Trial summary
The aim of this study was to evaluate the effects of periodontal treatment on gingival crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to systemically healthy CP patients. Read more about this study
- Who is it for?
- Ages 39 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Chronic Periodontitis
- What is being tested?
- Periodontal examination, GCF sampling and phase I therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Aug 2010
- 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 39 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- None of the patients had received periodontal treatment during the past 6 months and none had received antibiotic medication during the past 3 months.
- AMI+CP and CP groups were regarded as suitable for the study if they were affected by CP and had at least 16 teeth, including at least four molars in different quadrants at least two periodontal pocket at least 5mm in depth, with a minimum of 2mm attachment loss.
- Patients, who met the AMI diagnostic criteria, with or without persistent ST-segment elevation
Who cannot join
- Patients with neoplasias, liver cirrhosis, HIV infection, chronic renal failure, hypo or hyperparathyroidism, diabetes mellitus, chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and Chron's Disease
About this study
Official title: The Effect of Periodontal Therapy on Neopterin and Vascular Cell Adhesion Molecule-1 Levels in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
The aim of this study was to evaluate the effects of periodontal treatment on gingival crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to systemically healthy CP patients. The investigators' hypothesized that severe CP may play a role in initiating or exacerbating MI and there is an increased risk for AMI among systemically healthy persons affected with severe CP.
Read the detailed description
There are no studies specifically addressing the altered GCF profile concurrent with the onset of myocardial infarction acutely (i.e. in the first 24h) and no data are currently available about GCF Neopterin and VCAM-1 levels in AMI patients with chronic periodontitis. The present study aimed to assess whether GCF levels of CP patients with AMI have an alteration in GCF levels of Neopterin and VCAM-1, also assessed whether these alterations might be related to treatment of existing periodontitis in AMI patients. A total of 60 subjects (20 CP patients with AMI, 20 systemically healthy CP patients and 20 healthy controls) were included.GCF samples were analyzed baseline and after 3 and 6 months, probing pocket depth(PD), clinical attachment level (CAL),bleeding on probing (BOP) , gingival and plaque (PI) indices were recorded. Neopterin and VCAM-1 levels (concentration and total amount) were determined by enzyme linked immunosorbent assay (ELISA). Baseline periodontal examination of AMI patients and 24-48h GCF collection was carried out in their hospital bed under sufficient illumination using artificial light. Within a time period of 2 months after the proceeding infarction, none of the patients had received periodontal treatment. AMI patients underwent periodontal therapy after the stabilization of their condition with the consent from same cardiologist. Periodontal disease was diagnosed based on the 1999 classification system developed by Armitage, and a preoperative periapical radiograph was taken that provided baseline data in Faculty of Dentistry. Clinical index scores and GCF sampling were recorded before, 3 and 6 months after the periodontal treatment. All selected patients underwent a 2- to 4-week initial therapy, which included comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. In all patients a periodontal reevaluation was performed 4 weeks after phase I therapy, to confirm the suitability of the sites for periodontal surgery. Mucoperiosteal flap operation was performed in cases where needed. The blood samples for serum were centrifuged for 10 min at 11.00RPM separating the serum from the cells. The serum samples were then immediately divided into 0.2-0.5ml aliquots and stored at -80°C until required for analysis. Samples were assayed for N and VCAM-1 using quantitative enzyme immunoassays.
Micro-centrifuge tubes, containing periopaper strips with absorbed GCF sample, were allowed to reach room temperature and eluted using a centrifugal method.17 After centrifugation, the strips were removed and the fluid was assayed by ELISA for N and soluble VCAM-1.The levels of N and sVCAM-1 in serum and GCF samples were measured using ELISA kit , . The ELISA procedures were carried out according to the manufacturer's instructions.
- Conditions
- Myocardial Infarction, Chronic Periodontitis
- Being tested
- Periodontal examination, GCF sampling, phase I therapy
- Keywords
- Periodontitis, Periodontal-systemic disease, Cardiovascular diseases, Gingival crevicular fluid, Acute myocardial infarction, Neopterin, Vascular cell adhesion molecule-1
- Medical subject headings
- Myocardial Infarction, Chronic Periodontitis, Periodontitis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examinationProcedure or surgery
periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL).
All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements
GCF samplingProcedure or surgery
GCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s.
phase I therapyProcedure or surgery
comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
| Study group | Role | What they receive |
|---|---|---|
| AMI+CP: | Experimental | GCF sampling,periodontal examination,phase I therapy:
Patients, who met the AMI diagnostic criteria with chronic periodontitis. Baseline periodontal examination of AMI patients and 24-48h GCF sampling was carried out in their hospital bed under sufficient illumination using artificial light. Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. Mucoperiosteal flap operation was performed in cases where needed. Receives: Procedure: Periodontal examination; Procedure: GCF sampling; Procedure: phase I therapy |
| Chronic Periodontitis (CP) | Active comparator | GCF sampling,periodontal examination,phase I therapy:
Systemically healthy chronic periodontitis patients.Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology.Mucoperiosteal flap operation was performed in cases where needed. Receives: Procedure: Periodontal examination; Procedure: GCF sampling; Procedure: phase I therapy |
| Healthy controls | Sham comparator | clinically healthy individuals not having any periodontal and systemic diseases history.Comprehensive medical and periodontal examination to confirm that they did not have systemic and periodontal diseases Receives: Procedure: Periodontal examination; Procedure: GCF sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration and total amount of serum and GCF VCAM-1 and Neopterin
Using the standards included with the Enzyme-Linked ImmunoSorbent Assay (ELISA) kit. The concentrations of Neopterin and sVCAM-1 were expressed as ng/ml. Total amounts were also calculated by multiplying concentrations and GCF volumes(ml) and expressed as ng.
Measured: Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.
Secondary outcomes (1)
Clinical attachment level(CAL)
CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.
Measured: Baseline, 3 and 6 months after initial periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startAug 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Zeynep Turgut Çankaya, Gazi University
- Investigators
- Zeynep Turgut Çankaya, PhD DDs, Principal investigator, Gazi UniversityAyşen Bodur, PhD DDS, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005886
- Sponsor's protocol ID
- 03/2006-30
- Status last verified
- Jul 2019
- First submitted
- 20 Dec 2016
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Clinical measurement records of periodontal and medical protocols can be shared with other researches. Researches should send an e-mail to principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Periodontal Therapy on Neopterin and Vascular Cell Adhesion Molecule-1 Levels in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03005886
- Acronym / sponsor ID
- 03/2006-30
- Conditions
- Myocardial Infarction, Chronic Periodontitis
- Keywords
- Periodontitis, Periodontal-systemic disease, Cardiovascular diseases, Gingival crevicular fluid, Acute myocardial infarction, Neopterin, Vascular cell adhesion molecule-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- Aug 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Dec 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.
The aim of this study was to evaluate the effects of periodontal treatment on gingival crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to systemically healthy CP patients. The investigators' hypothesized that severe CP may play a role in initiating or exacerbating MI and there is an increased risk for AMI among systemically healthy persons affected with severe CP.
Detailed description
There are no studies specifically addressing the altered GCF profile concurrent with the onset of myocardial infarction acutely (i.e. in the first 24h) and no data are currently available about GCF Neopterin and VCAM-1 levels in AMI patients with chronic periodontitis. The present study aimed to assess whether GCF levels of CP patients with AMI have an alteration in GCF levels of Neopterin and VCAM-1, also assessed whether these alterations might be related to treatment of existing periodontitis in AMI patients. A total of 60 subjects (20 CP patients with AMI, 20 systemically healthy CP patients and 20 healthy controls) were included.GCF samples were analyzed baseline and after 3 and 6 months, probing pocket depth(PD), clinical attachment level (CAL),bleeding on probing (BOP) , gingival and plaque (PI) indices were recorded. Neopterin and VCAM-1 levels (concentration and total amount) were determined by enzyme linked immunosorbent assay (ELISA). Baseline periodontal examination of AMI patients and 24-48h GCF collection was carried out in their hospital bed under sufficient illumination using artificial light. Within a time period of 2 months after the proceeding infarction, none of the patients had received periodontal treatment. AMI patients underwent periodontal therapy after the stabilization of their condition with the consent from same cardiologist. Periodontal disease was diagnosed based on the 1999 classification system developed by Armitage, and a preoperative periapical radiograph was taken that provided baseline data in Faculty of Dentistry. Clinical index scores and GCF sampling were recorded before, 3 and 6 months after the periodontal treatment. All selected patients underwent a 2- to 4-week initial therapy, which included comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. In all patients a periodontal reevaluation was performed 4 weeks after phase I therapy, to confirm the suitability of the sites for periodontal surgery. Mucoperiosteal flap operation was performed in cases where needed. The blood samples for serum were centrifuged for 10 min at 11.00RPM separating the serum from the cells. The serum samples were then immediately divided into 0.2-0.5ml aliquots and stored at -80°C until required for analysis. Samples were assayed for N and VCAM-1 using quantitative enzyme immunoassays.
Micro-centrifuge tubes, containing periopaper strips with absorbed GCF sample, were allowed to reach room temperature and eluted using a centrifugal method.17 After centrifugation, the strips were removed and the fluid was assayed by ELISA for N and soluble VCAM-1.The levels of N and sVCAM-1 in serum and GCF samples were measured using ELISA kit , . The ELISA procedures were carried out according to the manufacturer's instructions.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMI+CP: | Experimental | Procedure: Periodontal examination, Procedure: GCF sampling, Procedure: phase I therapyGCF sampling,periodontal examination,phase I therapy: Patients, who met the AMI diagnostic criteria with chronic periodontitis. Baseline periodontal examination of AMI patients and 24-48h GCF sampling was carried out in their hospital bed under sufficient illumination using artificial light. Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology. Mucoperiosteal flap operation was performed in cases where needed. |
| Chronic Periodontitis (CP) | Active comparator | Procedure: Periodontal examination, Procedure: GCF sampling, Procedure: phase I therapyGCF sampling,periodontal examination,phase I therapy: Systemically healthy chronic periodontitis patients.Phase I periodontal therapy including comprehensive proper plaque control program, scaling, subgingival curettage and root planning in Department of Periodontology.Mucoperiosteal flap operation was performed in cases where needed. |
| Healthy controls | Sham comparator | Procedure: Periodontal examination, Procedure: GCF samplingclinically healthy individuals not having any periodontal and systemic diseases history.Comprehensive medical and periodontal examination to confirm that they did not have systemic and periodontal diseases |
Who may qualify
- Ages
- 39 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- None of the patients had received periodontal treatment during the past 6 months and none had received antibiotic medication during the past 3 months.
- AMI+CP and CP groups were regarded as suitable for the study if they were affected by CP and had at least 16 teeth, including at least four molars in different quadrants at least two periodontal pocket at least 5mm in depth, with a minimum of 2mm attachment loss.
- Patients, who met the AMI diagnostic criteria, with or without persistent ST-segment elevation
Key exclusion criteria (1 listed)
- Patients with neoplasias, liver cirrhosis, HIV infection, chronic renal failure, hypo or hyperparathyroidism, diabetes mellitus, chronic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and Chron's Disease
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 examinationperiodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL). All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements | Procedure or surgery | AMI+CP:, Chronic Periodontitis (CP), Healthy controls |
| GCF samplingGCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s. | Procedure or surgery | AMI+CP:, Chronic Periodontitis (CP), Healthy controls |
| phase I therapycomprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning | Procedure or surgery | AMI+CP:, Chronic Periodontitis (CP) |
Primary outcome
Concentration and total amount of serum and GCF VCAM-1 and Neopterin
Time frame: Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.
Using the standards included with the Enzyme-Linked ImmunoSorbent Assay (ELISA) kit. The concentrations of Neopterin and sVCAM-1 were expressed as ng/ml. Total amounts were also calculated by multiplying concentrations and GCF volumes(ml) and expressed as ng.
1 secondary outcome
Clinical attachment level(CAL)
Time frame: Baseline, 3 and 6 months after initial periodontal treatment
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 Jul 2019.
- Individual participant dataSharing planned: Yes. Clinical measurement records of periodontal and medical protocols can be shared with other researches. Researches should send an e-mail to principal investigator.
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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.
Zeynep Turgut Çankaya, PhD DDs principal investigator
Gazi University
Ayşen Bodur, PhD DDS study director
Gazi University
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal examination, GCF sampling and phase I therapy in people with Myocardial Infarction and Chronic Periodontitis, run by Gazi 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 3 inclusion and 1 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 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Concentration and total amount of serum and GCF VCAM-1 and Neopterin (time frame: Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.). 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 Jul 2019.