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

Third Molar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696369
• Other study ID #: HU-015
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2016
• Last updated: March 1, 2016
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Third Molar

Intervention

Drug:
• 2% lidocaine HCl with epinephrine 1:200,000

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

Locations

Country	Name	City	State
Korea, Republic of	Huons	Ansan	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain visual analogue scale (VAS)	To acess the pain immediately after the surgical extraction of impacted lower third molars	Immediately after the extraction	No
Secondary	Onset time of anesthesia		Immediately after administration of IP	No
Secondary	Local anesthetic duration		Immediately after onset of anesthesia	No
Secondary	Pain VAS		2, 4, 6 hours after administration of the investigational product (IP)	No
Secondary	Onset time of pain after administration of IP		Immediately after injection	No
Secondary	Bleeding after extraction measured by the operator		Immediately after extraction	No
Secondary	Questionnaire of satisfaction level of the operator		Immediately after extraction	No
Secondary	Questionnaire of satisfaction level of the subjects		Immediately after extraction	No
Secondary	Dosage of administrated IP		immediately after injection	No