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

Huons Co., Ltd.65 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Third Molar

Interventions

2% lidocaine HCl with epinephrine 1:200,000DRUG

2% lidocaine HCl with epinephrine 1:80,000DRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Huons

Ansan, Kyeonggi-do, South Korea

Outcomes

Primary Outcomes

Pain visual analogue scale (VAS)

To acess the pain immediately after the surgical extraction of impacted lower third molars

Time frame: Immediately after the extraction

Secondary Outcomes

Onset time of anesthesia

Time frame: Immediately after administration of IP

Local anesthetic duration

Time frame: Immediately after onset of anesthesia

Pain VAS

Time frame: 2, 4, 6 hours after administration of the investigational product (IP)

Onset time of pain after administration of IP

Time frame: Immediately after injection

Bleeding after extraction measured by the operator

Time frame: Immediately after extraction

Questionnaire of satisfaction level of the operator

Time frame: Immediately after extraction

Questionnaire of satisfaction level of the subjects

Time frame: Immediately after extraction

Dosage of administrated IP

Time frame: immediately after injection

Data from ClinicalTrials.gov

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