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

Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02603198
• Other study ID #: 34147114500000068
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2015
• Last updated: May 10, 2016
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Pain
• Trismus

Intervention

Drug:
• mepivacaine chloridrato epinephrine
local anesthesia for tooth removal
• mepivacaine chloridrato levonordefrin
local anesthesia for tooth removal

Locations

Country	Name	City	State
Brazil	Maria Cristina Zindel Deboni	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. Review. — View 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. — View Citation

Pellicer-Chover H, Cervera-Ballester J, Sanchis-Bielsa JM, Peñarrocha-Diago MA, Peñarrocha-Diago M, García-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. — View Citation

Serrera Figallo MA, Velázquez Cayón 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. Review. — View Citation

Torres-Lagares D, Serrera-Figallo MÁ, Machuca-Portillo G, Corcuera-Flores JR, Machuca-Portillo C, Castillo-Oyagüe R, Gutiérrez-Pérez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Blood pressure values	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	Yes
Secondary	Change in Heart Rate values	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	Yes
Secondary	Bleeding	Assessment by a visual analogical scale - blinded observer record	after 1 hour postoperatively	Yes
Secondary	Pain	assessment by visual Analogical Scale - Patient diary	6, 8,24 and 48 hours after suture	No