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Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01910337
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Renata Martins da Silva Prado, University of Sao Paulo

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Patients Device: Use the Polar Cardiac rate meter

Study Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
Study Start Date : June 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : March 2012
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of cardiac safety during third molar surgeries [ Time Frame: 3 weekes ]

Secondary Outcome Measures :
  1. study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter. [ Time Frame: 3 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 patients from the community sample in Dentistry School - University of Sao Paulo
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • smoking
  • pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910337


Locations
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Brazil
Faculdade de Odontologia da Universidade de são Paulo
São Paulo, Brazil, 05055-210
Sponsors and Collaborators
Renata Martins da Silva Prado
University of Sao Paulo
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Renata Martins da Silva Prado, 2926480, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01910337    
Other Study ID Numbers: FR335167
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013
Keywords provided by Renata Martins da Silva Prado, University of Sao Paulo:
ASA I patients