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

Periodontitis Clinical Trial

Official title:

Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150005
• Other study ID #: UVA71/06
• Status: Completed
• Phase: N/A
• First received: May 18, 2014
• Last updated: May 25, 2014
• Start date: January 2009

Study information

• Verified date: May 2014
• Source: Universidade Veiga de Almeida
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronariopathy
• Periodontitis

Intervention

Procedure:
• Periodontal treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Veiga de Almeida	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in probing depth in sites with PPD>3mm	Reduction of 11.4% in probing depth in sites with Periodontal Probing Depth>3mm	Baseline and 90 days after the initial exam	No
Primary	Reduction in probing depth in sites with PPD>5mm	Reduction of 6.3% in probing depth in sites with Periodontal Probing Depth>5mm	Baseline and 90 days after the initial exam	No
Primary	Reduction in probing depth in sites with CAL>3mm	Reduction of 4.6% in probing depth in sites with Clinical Attachment Level >3mm.	Baseline and 90 days after the initial exam	No
Primary	Reduction in probing depth in sites with CAL >5mm	Reduction of 3.6% in probing depth in sites with Clinical Attachment Level >5mm.	Baseline and 90 days after the initial exam	No
Primary	Leukocyte count	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	No
Primary	Glucose	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	No
Primary	Hemocyte	Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL	Baseline and 90 days after initial exam	No
Primary	Hemoglobin	Non-significant reduction in test group. Mean difference of 0.2 g/dL	Baseline and 90 days after initial exam	No
Primary	Total Cholesterol	Significant reduction in the test group. Mean reduction of 27.4 mg/dL.	Baseline and 90 days after initial exam	No
Primary	High density lipid	Significant reduction in test group. Mean difference of 8.2 mg/dL.	Baseline and 90 days after initial exam	No
Primary	Low density lipid	Non-significant reduction in test group. Mean difference of 8.9 mg/dL.	Baseline and 90 days after initial exam	No