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Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies

Primary Purpose

Periodontitis, Coronariopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Periodontal treatment
Sponsored by
Universidade Veiga de Almeida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontal diseases, cardiovascular diseases, periodontitis treatment

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing cardiovascular treatment;
  • Eight viable teeth in the oral cavity;
  • Four periodontal sites with periodontal probing depths ≥5mm in different teeth.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Periodontal treatment

    Control

    Arm Description

    The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.

    Outcomes

    Primary Outcome Measures

    Reduction in probing depth in sites with PPD>3mm
    Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
    Reduction in probing depth in sites with PPD>5mm
    Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
    Reduction in probing depth in sites with CAL>3mm
    Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
    Reduction in probing depth in sites with CAL >5mm
    Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
    Leukocyte count
    Non-significant reduction of leukocyte count in the test group. Mean difference of 74.6 m/mcL.
    Glucose
    Glucose showed a non-significant increase in the test group. Mean difference of 24.2 mg/dL.
    Hemocyte
    Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL
    Hemoglobin
    Non-significant reduction in test group. Mean difference of 0.2 g/dL
    Total Cholesterol
    Significant reduction in the test group. Mean reduction of 27.4 mg/dL.
    High density lipid
    Significant reduction in test group. Mean difference of 8.2 mg/dL.
    Low density lipid
    Non-significant reduction in test group. Mean difference of 8.9 mg/dL.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 18, 2014
    Last Updated
    May 25, 2014
    Sponsor
    Universidade Veiga de Almeida
    Collaborators
    Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02150005
    Brief Title
    Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
    Official Title
    Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Veiga de Almeida
    Collaborators
    Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization. Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Coronariopathy
    Keywords
    periodontal diseases, cardiovascular diseases, periodontitis treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Periodontal treatment
    Arm Type
    Experimental
    Arm Description
    The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Periodontal treatment
    Primary Outcome Measure Information:
    Title
    Reduction in probing depth in sites with PPD>3mm
    Description
    Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Reduction in probing depth in sites with PPD>5mm
    Description
    Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Reduction in probing depth in sites with CAL>3mm
    Description
    Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Reduction in probing depth in sites with CAL >5mm
    Description
    Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Leukocyte count
    Description
    Non-significant reduction of leukocyte count in the test group. Mean difference of 74.6 m/mcL.
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Glucose
    Description
    Glucose showed a non-significant increase in the test group. Mean difference of 24.2 mg/dL.
    Time Frame
    Baseline and 90 days after the initial exam
    Title
    Hemocyte
    Description
    Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL
    Time Frame
    Baseline and 90 days after initial exam
    Title
    Hemoglobin
    Description
    Non-significant reduction in test group. Mean difference of 0.2 g/dL
    Time Frame
    Baseline and 90 days after initial exam
    Title
    Total Cholesterol
    Description
    Significant reduction in the test group. Mean reduction of 27.4 mg/dL.
    Time Frame
    Baseline and 90 days after initial exam
    Title
    High density lipid
    Description
    Significant reduction in test group. Mean difference of 8.2 mg/dL.
    Time Frame
    Baseline and 90 days after initial exam
    Title
    Low density lipid
    Description
    Non-significant reduction in test group. Mean difference of 8.9 mg/dL.
    Time Frame
    Baseline and 90 days after initial exam

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Undergoing cardiovascular treatment; Eight viable teeth in the oral cavity; Four periodontal sites with periodontal probing depths ≥5mm in different teeth. Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies

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