2%-Mepivacaine With Two Different Vasoconstrictors Solutions in Third Molar Surgery a Comparative Study
Primary Purpose
Pain, Trismus, Edema
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
mepivacaine chloridrato epinephrine
mepivacaine chloridrato levonordefrin
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring third molar, tooth extraction, impacted tooth
Eligibility Criteria
Inclusion Criteria:
- minimum body weight of 50Kg, necessity of bilateral impacted third molar removal
Exclusion Criteria:
-
Sites / Locations
- Maria Cristina Zindel Deboni
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
mepivacaine chloridrato epinephrine
mepivacaine chloridrato levonordefrin
Arm Description
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:100.000 epinephrine, maximum of 4 cartridges
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:20.000 levonordefrin, maximum of 4 cartridges
Outcomes
Primary Outcome Measures
Change in Blood pressure values
assessment of blood pressure values (systolic and diastolic)) in mmHg by a pulse electronic device
Secondary Outcome Measures
Change in Heart Rate values
assessment of Heart Rate in bpm (beats per minute) by a pulse electronic device
Bleeding
Assessment by a visual analogical scale - blinded observer record
Pain
assessment by visual Analogical Scale - Patient diary
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02603198
Brief Title
2%-Mepivacaine With Two Different Vasoconstrictors Solutions in Third Molar Surgery a Comparative Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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:
20minutes before surgical procedure with patients in awaiting room;
5 minutes before procedure with patient seated in dental chair;
5 minutes after anesthesia procedure;
during osteotomy/tooth sectioning and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Trismus, Edema
Keywords
third molar, tooth extraction, impacted tooth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mepivacaine chloridrato epinephrine
Arm Type
Active Comparator
Arm Description
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:100.000 epinephrine, maximum of 4 cartridges
Arm Title
mepivacaine chloridrato levonordefrin
Arm Type
Active Comparator
Arm Description
Side of operation that is going to receive anesthesia with 2% mepivacaine chloridrato with 1:20.000 levonordefrin, maximum of 4 cartridges
Intervention Type
Drug
Intervention Name(s)
mepivacaine chloridrato epinephrine
Other Intervention Name(s)
local anesthesia
Intervention Description
local anesthesia for tooth removal
Intervention Type
Drug
Intervention Name(s)
mepivacaine chloridrato levonordefrin
Other Intervention Name(s)
local anesthesia
Intervention Description
local anesthesia for tooth removal
Primary Outcome Measure Information:
Title
Change in Blood pressure values
Description
assessment of blood pressure values (systolic and diastolic)) in mmHg by a pulse electronic device
Time Frame
20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
Secondary Outcome Measure Information:
Title
Change in Heart Rate values
Description
assessment of Heart Rate in bpm (beats per minute) by a pulse electronic device
Time Frame
20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
Title
Bleeding
Description
Assessment by a visual analogical scale - blinded observer record
Time Frame
after 1 hour postoperatively
Title
Pain
Description
assessment by visual Analogical Scale - Patient diary
Time Frame
6, 8,24 and 48 hours after suture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
minimum body weight of 50Kg, necessity of bilateral impacted third molar removal
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Minharro Cechetti, PhD
Organizational Affiliation
Post - Doctorate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cristina Zindel Deboni
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20835569
Citation
Ezmek B, Arslan A, Delilbasi C, Sencift K. Comparison of hemodynamic effects of lidocaine, prilocaine and mepivacaine solutions without vasoconstrictor in hypertensive patients. J Appl Oral Sci. 2010 Jul-Aug;18(4):354-9. doi: 10.1590/s1678-77572010000400006.
Results Reference
background
PubMed Identifier
20831932
Citation
Hersh EV, Giannakopoulos H. Beta-adrenergic blocking agents and dental vasoconstrictors. Dent Clin North Am. 2010 Oct;54(4):687-96. doi: 10.1016/j.cden.2010.06.009.
Results Reference
background
PubMed Identifier
24558534
Citation
Serrera Figallo MA, Velazquez Cayon RT, Torres Lagares D, Corcuera Flores JR, Machuca Portillo G. Use of anesthetics associated to vasoconstrictors for dentistry in patients with cardiopathies. Review of the literature published in the last decade. J Clin Exp Dent. 2012 Apr 1;4(2):e107-11. doi: 10.4317/jced.50590. eCollection 2012 Apr.
Results Reference
background
PubMed Identifier
24455059
Citation
Pellicer-Chover H, Cervera-Ballester J, Sanchis-Bielsa JM, Penarrocha-Diago MA, Penarrocha-Diago M, Garcia-Mira B. Comparative split-mouth study of the anesthetic efficacy of 4% articaine versus 0.5% bupivacaine in impacted mandibular third molar extraction. J Clin Exp Dent. 2013 Apr 1;5(2):e66-71. doi: 10.4317/jced.50869. eCollection 2013 Apr 1.
Results Reference
background
PubMed Identifier
22322521
Citation
Torres-Lagares D, Serrera-Figallo MA, Machuca-Portillo G, Corcuera-Flores JR, Machuca-Portillo C, Castillo-Oyague R, Gutierrez-Perez JL. Cardiovascular effect of dental anesthesia with articaine (40 mg with epinefrine 0,5 mg % and 40 mg with epinefrine 1 mg%) versus mepivacaine (30 mg and 20 mg with epinefrine 1 mg%) in medically compromised cardiac patients: a cross-over, randomized, single blinded study. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e655-60. doi: 10.4317/medoral.17892.
Results Reference
background
PubMed Identifier
21174567
Citation
Lawaty I, Drum M, Reader A, Nusstein J. A prospective, randomized, double-blind comparison of 2% mepivacaine with 1 : 20,000 levonordefrin versus 2% lidocaine with 1 : 100,000 epinephrine for maxillary infiltrations. Anesth Prog. 2010 Winter;57(4):139-44. doi: 10.2344/0003-3006-57.4.139.
Results Reference
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2%-Mepivacaine With Two Different Vasoconstrictors Solutions in Third Molar Surgery a Comparative Study
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