Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

Study Overview
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Brief Summary
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This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars

Official Title
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A Multi-center, Randomized, Double-blind, Crossover, phase4 Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

Conditions
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Third Molar

Intervention / Treatment
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* Drug: 2% lidocaine HCl with epinephrine 1:200,000
* Drug: 2% lidocaine HCl with epinephrine 1:80,000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 19 Physical grade 1 or 2 by American Society of Anesthesiologists (ASA) Mesioangular or horizontal angulation categorized by winter classification Exclusion Criteria: Allergy or hypersensitivity about the investigated products Any infection or edema during the extraction The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders Pregnancy or breast-feeding Any conditions that the investigator considers not to appropriate for this study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% Lidocaine HCL:Epinephrine inj.<br>2% Lidocaine HCL with epinephrine 1:200,000 | Drug: 2% lidocaine HCl with epinephrine 1:200,000<br> <br> |
| Active Comparator: 2% Lidocaine HCL:Epinephrine inj. (3M)<br>2% Lidocaine HCl with epinephrine 1:80,000 | Drug: 2% lidocaine HCl with epinephrine 1:80,000<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain visual analogue scale (VAS) | To acess the pain immediately after the surgical extraction of impacted lower third molars | Immediately after the extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time of anesthesia |  | Immediately after administration of IP | 
| Local anesthetic duration |  | Immediately after onset of anesthesia | 
| Pain VAS |  | 2, 4, 6 hours after administration of the investigational product (IP) | 
| Onset time of pain after administration of IP |  | Immediately after injection | 
| Bleeding after extraction measured by the operator |  | Immediately after extraction | 
| Questionnaire of satisfaction level of the operator |  | Immediately after extraction | 
| Questionnaire of satisfaction level of the subjects |  | Immediately after extraction | 
| Dosage of administrated IP |  | immediately after injection |