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

H

Huons

Status and phase

Completed
Phase 4

Conditions

Third Molar

Treatments

Drug: 2% lidocaine HCl with epinephrine 1:80,000
Drug: 2% lidocaine HCl with epinephrine 1:200,000

Study type

Interventional

Funder types

Industry

Identifiers

NCT02696369
HU-015

Details and patient eligibility

About

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

Enrollment

65 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

65 participants in 2 patient groups

2% Lidocaine HCL:Epinephrine inj.
Experimental group
Description:
2% Lidocaine HCL with epinephrine 1:200,000
Treatment:
Drug: 2% lidocaine HCl with epinephrine 1:200,000
2% Lidocaine HCL:Epinephrine inj. (3M)
Active Comparator group
Description:
2% Lidocaine HCl with epinephrine 1:80,000
Treatment:
Drug: 2% lidocaine HCl with epinephrine 1:80,000

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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