NCT02150005

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

1.9 years

First QC Date

May 18, 2014

Last Update Submit

May 25, 2014

Conditions

PeriodontitisCoronariopathy

Keywords

periodontal diseasescardiovascular diseasesperiodontitis treatment

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Hemocyte

    Hemocyte presented a non-significant reduction in the test group. Mean difference 0.39 m/mcL

    Baseline and 90 days after initial exam

  • Hemoglobin

    Non-significant reduction in test group. Mean difference of 0.2 g/dL

    Baseline and 90 days after initial exam

  • Total Cholesterol

    Significant reduction in the test group. Mean reduction of 27.4 mg/dL.

    Baseline and 90 days after initial exam

  • High density lipid

    Significant reduction in test group. Mean difference of 8.2 mg/dL.

    Baseline and 90 days after initial exam

  • Low density lipid

    Non-significant reduction in test group. Mean difference of 8.9 mg/dL.

    Baseline and 90 days after initial exam

Study Arms (2)

Periodontal treatment

EXPERIMENTAL

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

Procedure: Periodontal treatment

Control

NO INTERVENTION

Interventions

Periodontal treatmentPROCEDURE
Periodontal treatment

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesCardiovascular Diseases

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 29, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Last Updated

May 29, 2014

Record last verified: 2014-05