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

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