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

• Sponsor: Huons Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02696369
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Third Molar	Drug: 2% lidocaine HCl with epinephrine 1:200,000; Drug: 2% lidocaine HCl with epinephrine 1:80,000	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Onset time of anesthesia [Immediately after administration of IP]

2. Local anesthetic duration [Immediately after onset of anesthesia]

3. Pain VAS [2, 4, 6 hours after administration of the investigational product (IP)]

4. Onset time of pain after administration of IP [Immediately after injection]

5. Bleeding after extraction measured by the operator [Immediately after extraction]

6. Questionnaire of satisfaction level of the operator [Immediately after extraction]

7. Questionnaire of satisfaction level of the subjects [Immediately after extraction]

8. Dosage of administrated IP [immediately after injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huons	Ansan	Kyeonggi-do	Korea, Republic of	426791

Sponsors and Collaborators

• Huons Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Huons Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02696369
• Other Study ID Numbers: HU-015
• First Posted: Mar 2, 2016
• Last Update Posted: Mar 2, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Tooth, Impacted; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

No Results Posted as of Mar 2, 2016