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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02696369

Enrollment

Registered

2016-03-02

Start date

2014-12-31

Completion date

2015-08-31

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Third Molar

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

Interventions

DRUG2% lidocaine HCl with epinephrine 1:200,000

DRUG2% lidocaine HCl with epinephrine 1:80,000

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pain visual analogue scale (VAS)	Immediately after the extraction	To acess the pain immediately after the surgical extraction of impacted lower third molars

Secondary

Measure	Time frame
Local anesthetic duration	Immediately after onset of anesthesia
Pain VAS	2, 4, 6 hours after administration of the investigational product (IP)
Onset time of pain after administration of IP	Immediately after injection
Onset time of anesthesia	Immediately after administration of IP
Questionnaire of satisfaction level of the operator	Immediately after extraction
Questionnaire of satisfaction level of the subjects	Immediately after extraction
Dosage of administrated IP	immediately after injection
Bleeding after extraction measured by the operator	Immediately after extraction

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026