Back to resultsTrial 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
Primary Purpose
Third Molar
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
2% lidocaine HCl with epinephrine 1:200,000
2% lidocaine HCl with epinephrine 1:80,000
Sponsored by
About this trial
This is an interventional treatment trial for Third Molar
Eligibility Criteria
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
Sites / Locations
- Huons
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2% Lidocaine HCL:Epinephrine inj.
2% Lidocaine HCL:Epinephrine inj. (3M)
Arm Description
2% Lidocaine HCL with epinephrine 1:200,000
2% Lidocaine HCl with epinephrine 1:80,000
Outcomes
Primary Outcome Measures
Pain visual analogue scale (VAS)
To acess the pain immediately after the surgical extraction of impacted lower third molars
Secondary Outcome Measures
Onset time of anesthesia
Local anesthetic duration
Pain VAS
Onset time of pain after administration of IP
Bleeding after extraction measured by the operator
Questionnaire of satisfaction level of the operator
Questionnaire of satisfaction level of the subjects
Dosage of administrated IP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02696369
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Molar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2% Lidocaine HCL:Epinephrine inj.
Arm Type
Experimental
Arm Description
2% Lidocaine HCL with epinephrine 1:200,000
Arm Title
2% Lidocaine HCL:Epinephrine inj. (3M)
Arm Type
Active Comparator
Arm Description
2% Lidocaine HCl with epinephrine 1:80,000
Intervention Type
Drug
Intervention Name(s)
2% lidocaine HCl with epinephrine 1:200,000
Intervention Type
Drug
Intervention Name(s)
2% lidocaine HCl with epinephrine 1:80,000
Primary Outcome Measure Information:
Title
Pain visual analogue scale (VAS)
Description
To acess the pain immediately after the surgical extraction of impacted lower third molars
Time Frame
Immediately after the extraction
Secondary Outcome Measure Information:
Title
Onset time of anesthesia
Time Frame
Immediately after administration of IP
Title
Local anesthetic duration
Time Frame
Immediately after onset of anesthesia
Title
Pain VAS
Time Frame
2, 4, 6 hours after administration of the investigational product (IP)
Title
Onset time of pain after administration of IP
Time Frame
Immediately after injection
Title
Bleeding after extraction measured by the operator
Time Frame
Immediately after extraction
Title
Questionnaire of satisfaction level of the operator
Time Frame
Immediately after extraction
Title
Questionnaire of satisfaction level of the subjects
Time Frame
Immediately after extraction
Title
Dosage of administrated IP
Time Frame
immediately after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Huons
City
Ansan
State/Province
Kyeonggi-do
ZIP/Postal Code
426791
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs