2%-Mepivacaine With Two Different Vasoconstrictors Solutions in Third Molar Surgery a Comparative Study

May 10, 2016 updated by: Maria Cristina Zindel Deboni, University of Sao Paulo

2%-Mepivacaine With Two Different Vasoconstrictors; 1:20.000 Levonordefrin or 1:100.000 Epinephrin for Local Anesthesia in Third Molar Surgery: A Comparative Randomized Clinical Trial

Dental treatments, particularly third molars extraction, can become extremely uncomfortable and painful. They are associated to anxiety, fear and many other unpleasant sensations. During surgery, patients can present cardiorespiratory repercussions of these sensations. This fact generally justifies the employment of methods of monitoring and appliance of safer therapeutic alternatives. Local anesthetics are the most frequently drugs used in dentistry. Vasoconstrictors, particularly epinephrine, are important components of anesthetic solutions to increased time for anesthetic absorption and consequently increasing the duration of anesthesia. The use of smaller amounts of anesthetic solution can reduce the risk of systemic toxicity, however decrease the total surgical time. It is well known that the amount of epinephrine injected into patients during anesthetic procedures can produce adverse hemodynamic effects. Levonordefrin was adding to dental cartridges promising to reduce cardiac stimulation due it less β activity, and maintain the same clinical and systemic effects. But some studies for maxillary or intraosseous infiltrations showed no difference in heart rate and any anesthetic success over epinephrine. Thus, this study aims to compare the clinical efficacy and safety of anesthetic mepivacaine 2% with epinephrine 1:100,000 or 1:20,000 levonordefrin employing a clinical trial model of third molars extractions in healthy adults.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

30 healthy patients, both gender between 18 and 40 years-of-age with the necessity of bilateral third molar removal with similar surgical difficulty will be recruited from a Dental Public University Clinic. Inclusion criteria includes: non-smoking participants, minimum of 50 Kg of weight. After clinical and radiographic examination, they will be randomized accordingly to the side to be operated in two groups: MEPI-LEVO and MEPI-EPI. There will be a memory-washout of 15days between surgeries. In the MEPI-LEVO group, the patient will receive local anesthesia employing 2% chloridrato mepivacaine with 1:20.000 levonordefrin at a maximum of four cartridges of anesthesia. The other side will receive 2%chloridrato mepivacaine with 1:100.000 epinephrine in the same maximum amount. The surgery in both groups will follow strictly patterns of minimum surgical trauma and high cautious antiseptic conditions. The same surgeon will do the tooth extractions but the anesthesia will be done by another oral surgeon in order to blind the type of anesthetic solution from the operator (type of vasoconstrictor used). The amount of bleeding will be quantified just immediately after suture by a blinded observer that will record in a visual analogical scale between 0 and 10 points, where 0 correspond to absence of bleeding and 10 to excessive bleeding.

Blood pressure and heart rate will be accessed in five different moments:

  1. 20minutes before surgical procedure with patients in awaiting room;
  2. 5 minutes before procedure with patient seated in dental chair;
  3. 5 minutes after anesthesia procedure;
  4. during osteotomy/tooth sectioning and
  5. after 10 minutes of suturing.

Patients after surgery will receive a diary to record the time when anesthesia sensation had ended, the amount of analgesics they had consumed and the level of pain in a visual analogic scale. The data will be submitted to statistical analysis with p<0.05 of significance.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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, 05508-000
        • Maria Cristina Zindel Deboni

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • minimum body weight of 50Kg, necessity of bilateral impacted third molar removal

Exclusion Criteria:

-

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mepivacaine chloridrato epinephrine
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:100.000 epinephrine, maximum of 4 cartridges
Drug: mepivacaine chloridrato epinephrine
local anesthesia for tooth removal
Other Names:
  • local anesthesia
Active Comparator: mepivacaine chloridrato levonordefrin
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:20.000 levonordefrin, maximum of 4 cartridges
Drug: mepivacaine chloridrato levonordefrin
local anesthesia for tooth removal
Other Names:
  • local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood pressure values
Time Frame: 20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
assessment of blood pressure values (systolic and diastolic)) in mmHg by a pulse electronic device
20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Heart Rate values
Time Frame: 20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
assessment of Heart Rate in bpm (beats per minute) by a pulse electronic device
20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
Bleeding
Time Frame: after 1 hour postoperatively
Assessment by a visual analogical scale - blinded observer record
after 1 hour postoperatively
Pain
Time Frame: 6, 8,24 and 48 hours after suture
assessment by visual Analogical Scale - Patient diary
6, 8,24 and 48 hours after suture

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Marcelo Minharro Cechetti, PhD, Post - Doctorate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34147114500000068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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