- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150005
Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Periodontal treatment
The test group received oral hygiene instructions, supragingival and subgingival scaling and root planning using curettes and an ultrasonic appliance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in probing depth in sites with PPD>3mm
Time Frame: Baseline and 90 days after the initial exam
|
Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm
|
Baseline and 90 days after the initial exam
|
|
Reduction in probing depth in sites with PPD>5mm
Time Frame: Baseline and 90 days after the initial exam
|
Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm
|
Baseline and 90 days after the initial exam
|
|
Reduction in probing depth in sites with CAL>3mm
Time Frame: Baseline and 90 days after the initial exam
|
Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.
|
Baseline and 90 days after the initial exam
|
|
Reduction in probing depth in sites with CAL >5mm
Time Frame: Baseline and 90 days after the initial exam
|
Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.
|
Baseline and 90 days after the initial exam
|
|
Leukocyte count
Time Frame: Baseline and 90 days after the initial exam
|
Non-significant reduction of leukocyte count in the test group.
Mean difference of 74.6 m/mcL.
|
Baseline and 90 days after the initial exam
|
|
Glucose
Time Frame: Baseline and 90 days after the initial exam
|
Glucose showed a non-significant increase in the test group.
Mean difference of 24.2 mg/dL.
|
Baseline and 90 days after the initial exam
|
|
Hemocyte
Time Frame: Baseline and 90 days after initial exam
|
Hemocyte presented a non-significant reduction in the test group.
Mean difference 0.39 m/mcL
|
Baseline and 90 days after initial exam
|
|
Hemoglobin
Time Frame: Baseline and 90 days after initial exam
|
Non-significant reduction in test group.
Mean difference of 0.2 g/dL
|
Baseline and 90 days after initial exam
|
|
Total Cholesterol
Time Frame: Baseline and 90 days after initial exam
|
Significant reduction in the test group.
Mean reduction of 27.4 mg/dL.
|
Baseline and 90 days after initial exam
|
|
High density lipid
Time Frame: Baseline and 90 days after initial exam
|
Significant reduction in test group.
Mean difference of 8.2 mg/dL.
|
Baseline and 90 days after initial exam
|
|
Low density lipid
Time Frame: Baseline and 90 days after initial exam
|
Non-significant reduction in test group.
Mean difference of 8.9 mg/dL.
|
Baseline and 90 days after initial exam
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVA71/06
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