Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia

PHASE4CompletedINTERVENTIONAL
Enrollment

179

Participants

Timeline

Start Date

September 4, 2018

Primary Completion Date

January 31, 2020

Study Completion Date

March 30, 2020

Conditions
Drug EffectTooth Extraction
Interventions
DRUG

Articaine / EPINEPHrine Cartridge

The day scheduled for the surgery, vital signs (pulse, blood pressure and oxygen saturation) will be recorded prior the administration of the anesthesia. A volume of 1.8 ml of 4% articaine and epinephrine 1: 100000 solution of either the test product or the reference product will be deposited slowly to proceed to the inferior alveolar nerve block (IANB), according to the table of allocation of treatments in each period. The vital signs will continue to be monitored during the procedure, and once the procedure has been completed. If the volunteer needs more anesthetic, this will be recorded and will be administrated according to the maximum permitted doses (7 mg / kg (up to 500 mg) 5 mg / kg in children 7), and immediately after the administration, the vital signs will be taken again.

Trial Locations (1)

Unknown

University of Antioquia, Medellín

All Listed Sponsors
lead

Universidad de Antioquia

OTHER

NCT04166890 - Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia | Biotech Hunter | Biotech Hunter