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

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

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 Overview

• Status: Completed
• Conditions: Third Molar
• Intervention / Treatment: Drug: 2% lidocaine HCl with epinephrine 1:200,000; Drug: 2% lidocaine HCl with epinephrine 1:80,000

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyeonggi-do
    • Ansan, Kyeonggi-do, Korea, Republic of, 426791
      • Huons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: HU-015