Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

July 26, 2013 updated by: Renata Martins da Silva Prado
The purpose of this study is to use heart rate variability as a monitor of cardiovascular safety during third molar surgeries, using the Polar heart rate-meter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05055-210
        • Faculdade de Odontologia da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 patients from the community sample in Dentistry School - University of Sao Paulo

Description

Inclusion Criteria:

  • Healthy Patients (ASA I)
  • Need to remove one of Lower Third Molar.

Exclusion Criteria:

  • smoking
  • pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening
this first day, the patient will be evaluated with polar and blood pressure monitor. These data will be the basal one.
Device: Use the Polar Cardiac rate meter
Intervation
One week later the screening, the patient underwent to the surgery to remove his lower third molar. In this day, will be analyzed 4 points: basal, after the anesthesia, after the avulsion and 20 minutes after the surgery.
Device: Use the Polar Cardiac rate meter
Post operative
One week later the surgery, the patients will be evaluated again.
Device: Use the Polar Cardiac rate meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of cardiac safety during third molar surgeries
Time Frame: 3 weekes
3 weekes

Secondary Outcome Measures

Outcome Measure
Time Frame
study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter.
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renata Martins da Silva Prado

Collaborators

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 26, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FR335167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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