Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

Healthy Patients Clinical Trial

Official title:

Evaluation of Heart Rate Variability in Third Lower Molars Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910337
• Other study ID #: FR335167
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: July 26, 2013
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy Patients (ASA I)

• Need to remove one of Lower Third Molar.

Exclusion Criteria:

• smoking

• pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Patients

Intervention

Device:
• Use the Polar Cardiac rate meter

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia da Universidade de são Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Renata Martins da Silva Prado	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of cardiac safety during third molar surgeries		3 weekes	No
Secondary	study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter.		3 weeks	No