Healthy PatientsNCT01910337
Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
An observational study of Healthy Patients, run by Renata Martins da Silva Prado at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Patients
- What is being tested?
- Use the Polar Cardiac rate meter
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 30 patients from the community sample in Dentistry School - University of Sao Paulo
Who may be able to join
- Healthy Patients (ASA I)
- Need to remove one of Lower Third Molar.
Who cannot join
- smoking
- pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia da Universidade de são Paulo
São Paulo, São Paulo, 05055-210
About this study
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.
- Conditions
- Healthy Patients
- Being tested
- Use the Polar Cardiac rate meter
- Keywords
- ASA I patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use the Polar Cardiac rate meterDevice
| Study group | Role | What they receive |
|---|---|---|
| Screening | this first day, the patient will be evaluated with polar and blood pressure monitor. These data will be the basal one. Receives: 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. Receives: Device: Use the Polar Cardiac rate meter | |
| Post operative | One week later the surgery, the patients will be evaluated again. Receives: Device: Use the Polar Cardiac rate meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cardiac safety during third molar surgeries
Measured: 3 weekes
Secondary outcomes (1)
study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renata Martins da Silva Prado
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Sponsor-investigator, Renata Martins da Silva Prado, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910337
- Sponsor's protocol ID
- FR335167
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2013
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
- ClinicalTrials.gov ID
- NCT01910337
- Acronym / sponsor ID
- FR335167
- Conditions
- Healthy Patients
- Keywords
- ASA I patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Renata Martins da Silva PradoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Device: Use the Polar Cardiac rate meterthis first day, the patient will be evaluated with polar and blood pressure monitor. These data will be the basal one. |
| Intervation | – | Device: Use the Polar Cardiac rate meterOne 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. |
| Post operative | – | Device: Use the Polar Cardiac rate meterOne week later the surgery, the patients will be evaluated again. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 patients from the community sample in Dentistry School - University of Sao Paulo
Key inclusion criteria (2 listed)
- Healthy Patients (ASA I)
- Need to remove one of Lower Third Molar.
Key exclusion criteria (2 listed)
- smoking
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use the Polar Cardiac rate meter | Device | Intervation, Post operative, Screening |
Primary outcome
Evaluation of cardiac safety during third molar surgeries
Time frame: 3 weekes
1 secondary outcome
study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter.
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Patients, run by Renata Martins da Silva Prado at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cardiac safety during third molar surgeries (time frame: 3 weekes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2013.