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Completed

NCT Number: NCT02696369

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

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

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Key information

Conditions

Third Molar

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Huons

Ansan, Kyeonggi-do, 426791, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% lidocaine HCl with epinephrine 1:200,000

Drug

2% lidocaine HCl with epinephrine 1:80,000

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2016
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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