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

Phase 4

Completed

• Conditions: Third Molar

• Registration Number: NCT02696369
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Study First Posted: 2016-03-02
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain visual analogue scale (VAS)	Immediately after the extraction	To acess the pain immediately after the surgical extraction of impacted lower third molars

Secondary Outcome Measures

Name	Time	Method
Pain VAS	2, 4, 6 hours after administration of the investigational product (IP)
Bleeding after extraction measured by the operator	Immediately after extraction
Local anesthetic duration	Immediately after onset of anesthesia
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
Onset time of anesthesia	Immediately after administration of IP
Onset time of pain after administration of IP	Immediately after injection

Trial Locations

Locations (1)

Huons; 🇰🇷 Ansan, Kyeonggi-do, Korea, Republic of