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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

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ClinicalTrials.gov Identifier: NCT02696369
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


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



Primary Outcome Measures :
  1. Pain visual analogue scale (VAS) [ Time Frame: 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 [ Time Frame: Immediately after administration of IP ]
  2. Local anesthetic duration [ Time Frame: Immediately after onset of anesthesia ]
  3. Pain VAS [ Time Frame: 2, 4, 6 hours after administration of the investigational product (IP) ]
  4. Onset time of pain after administration of IP [ Time Frame: Immediately after injection ]
  5. Bleeding after extraction measured by the operator [ Time Frame: Immediately after extraction ]
  6. Questionnaire of satisfaction level of the operator [ Time Frame: Immediately after extraction ]
  7. Questionnaire of satisfaction level of the subjects [ Time Frame: Immediately after extraction ]
  8. Dosage of administrated IP [ Time Frame: immediately after injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696369


Locations
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Korea, Republic of
Huons
Ansan, Kyeonggi-do, Korea, Republic of, 426791
Sponsors and Collaborators
Huons Co., Ltd.
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Responsible Party: Huons Co., Ltd.
ClinicalTrials.gov Identifier: NCT02696369    
Other Study ID Numbers: HU-015
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents