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The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction, Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal examination
GCF sampling
phase I therapy
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Myocardial Infarction focused on measuring Periodontitis, Periodontal-systemic disease, Cardiovascular diseases, Gingival crevicular fluid, Acute myocardial infarction, Neopterin, Vascular cell adhesion molecule-1

Eligibility Criteria

39 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    AMI+CP:

    Chronic Periodontitis (CP)

    Healthy controls

    Arm 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.

    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.

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Clinical attachment level(CAL)
    CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.

    Full Information

    First Posted
    December 20, 2016
    Last Updated
    July 29, 2019
    Sponsor
    Gazi University
    Collaborators
    Ankara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03005886
    Brief Title
    The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University
    Collaborators
    Ankara University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction, Chronic Periodontitis
    Keywords
    Periodontitis, Periodontal-systemic disease, Cardiovascular diseases, Gingival crevicular fluid, Acute myocardial infarction, Neopterin, Vascular cell adhesion molecule-1

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AMI+CP:
    Arm Type
    Experimental
    Arm 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 Title
    Chronic Periodontitis (CP)
    Arm Type
    Active Comparator
    Arm 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 Title
    Healthy controls
    Arm Type
    Sham Comparator
    Arm 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(s)
    Periodontal examination
    Intervention 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
    Intervention Type
    Procedure
    Intervention Name(s)
    GCF sampling
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    phase I therapy
    Intervention Description
    comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
    Primary Outcome Measure Information:
    Title
    Concentration and total amount of serum and GCF VCAM-1 and Neopterin
    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.
    Time Frame
    Change from baseline concentration and total amount of serum&GCF sVCAM-1 and Neopterin at 6months.
    Secondary Outcome Measure Information:
    Title
    Clinical attachment level(CAL)
    Description
    CAL was calculated as the distance from cemento-enamel junction to bottom of gingival sulcus.
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Other Pre-specified Outcome Measures:
    Title
    Plaque Index
    Description
    Plaque Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Gingival Index
    Description
    Gingival Index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth.
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Probing Depth
    Description
    PD was recorded as the distance from the gingival margin to the most apical part of the sulcus.
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Bleeding on probing
    Description
    BOP is a widely used criterion to diagnose inflammation
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    39 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zeynep Turgut Çankaya, PhD DDs
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ayşen Bodur, PhD DDS
    Organizational Affiliation
    Gazi University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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 Sharing Time Frame
    The data will become available after the study paper published for one year period.
    IPD Sharing Access Criteria
    The statistical analysis in the published paper will be shared

    Learn more about this trial

    The Effect of Periodontal Therapy in Chronic Periodontitis Patients With and Without Acute Myocardial Infarction

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