<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005886</url>
  </required_header>
  <id_info>
    <org_study_id>03/2006-30</org_study_id>
    <nct_id>NCT03005886</nct_id>
  </id_info>
  <brief_title>The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the effects of periodontal treatment on gingival&#xD;
      crevicular fluid (GCF) levels of Neopterin(N) and vascular cell adhesion molecule (VCAM-1) in&#xD;
      chronic periodontitis(CP) patients with acute myocardial infarction(AMI) in comparison to&#xD;
      systemically healthy CP patients. The investigators' hypothesized that severe CP may play a&#xD;
      role in initiating or exacerbating MI and there is an increased risk for AMI among&#xD;
      systemically healthy persons affected with severe CP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are no studies specifically addressing the altered GCF profile concurrent with the&#xD;
      onset of myocardial infarction acutely (i.e. in the first 24h) and no data are currently&#xD;
      available about GCF Neopterin and VCAM-1 levels in AMI patients with chronic periodontitis.&#xD;
      The present study aimed to assess whether GCF levels of CP patients with AMI have an&#xD;
      alteration in GCF levels of Neopterin and VCAM-1, also assessed whether these alterations&#xD;
      might be related to treatment of existing periodontitis in AMI patients. A total of 60&#xD;
      subjects (20 CP patients with AMI, 20 systemically healthy CP patients and 20 healthy&#xD;
      controls) were included.GCF samples were analyzed baseline and after 3 and 6 months, probing&#xD;
      pocket depth(PD), clinical attachment level (CAL),bleeding on probing (BOP) , gingival and&#xD;
      plaque (PI) indices were recorded. Neopterin and VCAM-1 levels (concentration and total&#xD;
      amount) were determined by enzyme linked immunosorbent assay (ELISA). Baseline periodontal&#xD;
      examination of AMI patients and 24-48h GCF collection was carried out in their hospital bed&#xD;
      under sufficient illumination using artificial light. Within a time period of 2 months after&#xD;
      the proceeding infarction, none of the patients had received periodontal treatment. AMI&#xD;
      patients underwent periodontal therapy after the stabilization of their condition with the&#xD;
      consent from same cardiologist. Periodontal disease was diagnosed based on the 1999&#xD;
      classification system developed by Armitage, and a preoperative periapical radiograph was&#xD;
      taken that provided baseline data in Faculty of Dentistry. Clinical index scores and GCF&#xD;
      sampling were recorded before, 3 and 6 months after the periodontal treatment. All selected&#xD;
      patients underwent a 2- to 4-week initial therapy, which included comprehensive proper plaque&#xD;
      control program, scaling, subgingival curettage and root planning in Department of&#xD;
      Periodontology. In all patients a periodontal reevaluation was performed 4 weeks after phase&#xD;
      I therapy, to confirm the suitability of the sites for periodontal surgery. Mucoperiosteal&#xD;
      flap operation was performed in cases where needed. The blood samples for serum were&#xD;
      centrifuged for 10 min at 11.00RPM separating the serum from the cells. The serum samples&#xD;
      were then immediately divided into 0.2-0.5ml aliquots and stored at -80°C until required for&#xD;
      analysis. Samples were assayed for N and VCAM-1 using quantitative enzyme immunoassays.&#xD;
&#xD;
      Micro-centrifuge tubes, containing periopaper strips with absorbed GCF sample, were allowed&#xD;
      to reach room temperature and eluted using a centrifugal method.17 After centrifugation, the&#xD;
      strips were removed and the fluid was assayed by ELISA for N and soluble VCAM-1.The levels of&#xD;
      N and sVCAM-1 in serum and GCF samples were measured using ELISA kit , . The ELISA procedures&#xD;
      were carried out according to the manufacturer's instructions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2006</start_date>
  <completion_date type="Actual">August 2010</completion_date>
  <primary_completion_date type="Actual">August 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration and total amount of serum and GCF VCAM-1 and Neopterin</measure>
    <time_frame>Change from baseline concentration and total amount of serum&amp;GCF sVCAM-1 and Neopterin at 6months.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level(CAL)</measure>
    <time_frame>Baseline, 3 and 6 months after initial periodontal treatment</time_frame>
    <description>CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plaque Index</measure>
    <time_frame>Baseline, 3 and 6 months after initial periodontal treatment</time_frame>
    <description>Plaque Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gingival Index</measure>
    <time_frame>Baseline, 3 and 6 months after initial periodontal treatment</time_frame>
    <description>Gingival Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Probing Depth</measure>
    <time_frame>Baseline, 3 and 6 months after initial periodontal treatment</time_frame>
    <description>PD was recorded as the distance from the gingival margin to the most apical part of the sulcus.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>Baseline, 3 and 6 months after initial periodontal treatment</time_frame>
    <description>BOP is a widely used criterion to diagnose inflammation</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>AMI+CP:</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCF sampling,periodontal examination,phase I therapy:&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Periodontitis (CP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GCF sampling,periodontal examination,phase I therapy:&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal examination</intervention_name>
    <description>periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL).&#xD;
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</description>
    <arm_group_label>AMI+CP:</arm_group_label>
    <arm_group_label>Chronic Periodontitis (CP)</arm_group_label>
    <arm_group_label>Healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>GCF sampling</intervention_name>
    <description>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.</description>
    <arm_group_label>AMI+CP:</arm_group_label>
    <arm_group_label>Chronic Periodontitis (CP)</arm_group_label>
    <arm_group_label>Healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>phase I therapy</intervention_name>
    <description>comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning</description>
    <arm_group_label>AMI+CP:</arm_group_label>
    <arm_group_label>Chronic Periodontitis (CP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  None of the patients had received periodontal treatment during the past 6 months and&#xD;
             none had received antibiotic medication during the past 3 months.&#xD;
&#xD;
          -  AMI+CP and CP groups were regarded as suitable for the study if they were affected by&#xD;
             CP and had at least 16 teeth, including at least four molars in different quadrants at&#xD;
             least two periodontal pocket at least 5mm in depth, with a minimum of 2mm attachment&#xD;
             loss.&#xD;
&#xD;
          -  Patients, who met the AMI diagnostic criteria, with or without persistent ST-segment&#xD;
             elevation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neoplasias, liver cirrhosis, HIV infection, chronic renal failure, hypo&#xD;
             or hyperparathyroidism, diabetes mellitus, chronic inflammatory diseases (rheumatoid&#xD;
             arthritis, systemic lupus erythematosus, multiple sclerosis, and Chron's Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>39 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeynep Turgut Çankaya, PhD DDs</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayşen Bodur, PhD DDS</last_name>
    <role>Study Director</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Zeynep Turgut Çankaya</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Periodontitis</keyword>
  <keyword>Periodontal-systemic disease</keyword>
  <keyword>Cardiovascular diseases</keyword>
  <keyword>Gingival crevicular fluid</keyword>
  <keyword>Acute myocardial infarction</keyword>
  <keyword>Neopterin</keyword>
  <keyword>Vascular cell adhesion molecule-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Clinical measurement records of periodontal and medical protocols can be shared with other researches. Researches should send an e-mail to principal investigator.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data will become available after the study paper published for one year period.</ipd_time_frame>
    <ipd_access_criteria>The statistical analysis in the published paper will be shared</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005886
org study id: 03/2006-30
nct id: NCT03005886
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
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.
description: 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.
measure: Clinical attachment level(CAL)
time frame: Baseline, 3 and 6 months after initial periodontal treatment
description: CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.
measure: Plaque Index
time frame: Baseline, 3 and 6 months after initial periodontal treatment
description: Plaque Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.
measure: Gingival Index
time frame: Baseline, 3 and 6 months after initial periodontal treatment
description: Gingival Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.
measure: Probing Depth
time frame: Baseline, 3 and 6 months after initial periodontal treatment
description: PD was recorded as the distance from the gingival margin to the most apical part of the sulcus.
measure: Bleeding on probing
time frame: Baseline, 3 and 6 months after initial periodontal treatment
description: BOP is a widely used criterion to diagnose inflammation
arm group label: AMI+CP:
arm group type: Experimental
description: 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.
arm group label: Chronic Periodontitis (CP)
arm group type: Active Comparator
description: 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.
arm group label: Healthy controls
arm group type: Sham Comparator
description: 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
intervention type: Procedure
intervention name: Periodontal examination
description: 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
arm group label: AMI+CP:
arm group label: Chronic Periodontitis (CP)
arm group label: Healthy controls
intervention type: Procedure
intervention name: GCF sampling
description: 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.
arm group label: AMI+CP:
arm group label: Chronic Periodontitis (CP)
arm group label: Healthy controls
intervention type: Procedure
intervention name: phase I therapy
description: comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
arm group label: AMI+CP:
arm group label: Chronic Periodontitis (CP)
criteria: 
gender: All
minimum age: 39 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zeynep Turgut Çankaya, PhD DDs
role: Principal Investigator
affiliation: Gazi University
last name: Ayşen Bodur, PhD DDS
role: Study Director
affiliation: Gazi University
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Zeynep Turgut Çankaya
investigator title: Research Assistant
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: Yes
ipd description: Clinical measurement records of periodontal and medical protocols can be shared with other researches. Researches should send an e-mail to principal investigator.
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data will become available after the study paper published for one year period.
ipd access criteria: The statistical analysis in the published paper will be shared