Clinical trial NCT02603198: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Trismus
Edema
Keywords: third molar
tooth extraction
impacted tooth
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Blood pressure values
timeFrame: 20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
Secondary outcomes:
measure: Change in Heart Rate values
timeFrame: 20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture
measure: Bleeding
timeFrame: after 1 hour postoperatively
measure: Pain
timeFrame: 6, 8,24 and 48 hours after suture
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Maria Cristina Zindel Deboni
Study officials:
affiliation: Post - Doctorate
name: Marcelo Minharro Cechetti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.