NCT02603198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

10 months

First QC Date

November 8, 2015

Last Update Submit

May 10, 2016

Conditions

PainTrismusEdema

Keywords

third molartooth extractionimpacted tooth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Heart Rate values

    20 minutes pre-operatory, 5 minutes before surgery, 5 minutes after anesthesia, 10 minutes after suture

  • Bleeding

    after 1 hour postoperatively

  • Pain

    6, 8,24 and 48 hours after suture

Study Arms (2)

mepivacaine chloridrato epinephrine

ACTIVE COMPARATOR

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

mepivacaine chloridrato levonordefrin

ACTIVE COMPARATOR

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

Interventions

mepivacaine chloridrato epinephrineDRUG

local anesthesia for tooth removal

Also known as: local anesthesia
mepivacaine chloridrato epinephrine
mepivacaine chloridrato levonordefrinDRUG

local anesthesia for tooth removal

Also known as: local anesthesia
mepivacaine chloridrato levonordefrin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Cristina Zindel Deboni

São Paulo, São Paulo, 05508-000, Brazil

Location

Related 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. doi: 10.1590/s1678-77572010000400006.

    PMID: 20835569BACKGROUND

  • 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.

    PMID: 20831932BACKGROUND

  • 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.

    PMID: 24558534BACKGROUND

  • 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.

    PMID: 24455059BACKGROUND

  • 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.

    PMID: 22322521BACKGROUND

  • 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.

    PMID: 21174567BACKGROUND

MeSH Terms

Conditions

PainTrismusEdemaTooth, Impacted

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNervous System DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Marcelo Minharro Cechetti, PhD

    Post - Doctorate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2015

First Posted

November 11, 2015

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)